1-11-18 - matheson - plotkin - Vol. I - Cijepljenje.Info...1 Stanley Plotkin, M.D. 2 you think you...

TSG Reporting - Worldwide 877-702-9580

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2 STATE OF MICHIGAN IN THE CIRCUIT COURT FOR THE COUNTY OF OAKLAND

3 FAMILY DIVISION - - -

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5 LORI MATHESON, :f/k/a LORI ANN SCHMITT, :

6 Plaintiff, : :

7 vs. : CASE NO. : 2015-831539-DM

8 MICHAEL SCHMITT, : Defendant. :

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VIDEOTAPED DEPOSITION OF STANLEY A. PLOTKIN, M.D.11 New Hope, Pennsylvania

January 11, 201812

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23 Reported by:24 Maureen Broderick, RPR25 JOB NO. 135522


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3 January 11, 2018

8:30 a.m.

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6 Videotape deposition of STANLEY A.

7 PLOTKIN, M.D., taken at the Golden Plough Inn, 5883

8 Lower York Road, New Hope, Pennsylvania, before

9 Maureen E. Broderick, Registered Professional

10 Reporter and Notary Public in and of the

11 Commonwealth of Pennsylvania.

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2 APPEARANCES3 SIRI GLIMSTAD

Attorneys for Plaintiff4 200 Park Avenue

New York, NY 101665 BY: AARON SIRI, ESQ.

and6 MICHAEL W. REEDS

1038 E. West Maple7 Walled Lake, MI 48390

BY: AMY RUBY, ESQ.8

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10 (Via Telephone)KARLSTROM COONEY

11 Attorneys for Defendant 6480 Citation Drive

12 Clarkston, MI 48346BY: LAURA NIEUSMA, ESQ.

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15 ALSO PRESENT: Tom Leibman, Videographer16

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2 EXAMINATION INDEX3 WITNESS PAGE4 Stanley Plotkin, M.D.5 By Mr. Siri 116 EXHIBIT INDEX7 NAME DESCRIPTION PAGE8 Plaintiff9 Exhibit 1 Voices for Vaccines - 48

Mission10

Exhibit 2 Form 990 - Tax Form 4911

Exhibit 3 The Task Force For 5212 Global Health - Fact

Sheet13

Exhibit 4 Royalty Pharma Press 6414 Release15 Exhibit 5 12/15/15 Press Release 6916 Exhibit 6 Immunization Action 72

Coalition - IAC Funding17 201718 Exhibit 7 Attenuation of RA 27/3 77

Rubella Virus in WI-3819 Human Diploid Cells20 Exhibit 8 CV of Dr. Plotkin 7921 Exhibit 9 Conflicts of Interest 131

in Vaccine Policy22 Making - June 15, 200023 Exhibit 10 Highlights of 149

Prescribing Information24 - RECOMBIVAX HB25


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2 EXHIBIT INDEX3 NAME DESCRIPTION PAGE4 Exhibit 11 Highlights of 157

Prescribing Information5 - ENGERIX-B6 Exhibit 12 Poliovirus Vaccine 167

Inactivated - IPOL -7 Sanofi Pasteur8 Exhibit 13 M-M-R II Description 1709 Exhibit 14 Highlights of 178

Prescribing Information10 - ActHIB11 Exhibit 15 Highlights of 184

Prescribing Information12 - GARDASIL13 Exhibit 16 Vaccine In Autoimmunity 189

- Chapter Book14 (Retained by Counsel)15 Exhibit 17 A Study of Gardasil in 197

Preadolescents and16 Adolescents17 Exhibit 18 Highlights of 202

Prescribing Information18 - Enbrel19 Exhibit 19 Adverse Effects of 217

Pertussis and Rubella20 Vaccines21 Exhibit 20 Adverse Events 227

Associated with22 Childhood Vaccines23 Exhibit 21 Adverse Effects of 231

Vaccine - Evidence and24 Causality25


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2 EXHIBIT INDEX3 NAME DESCRIPTION PAGE4 Exhibit 22 Adverse Effects of 241

Vaccines: Evidence and5 Causality6 Exhibit 23 Professional Edition 264

for Physicians - 20157 ICD9-CM Excerpt8 Exhibit 24 Pilot Comparative Study 273

on the Health of9 Vaccinated and

Unvaccinated 6- to10 12-year-old U.S.

Children11

Exhibit 25 Preterm Birth, 27812 Vaccination and

Neurodevelopmental13 Disorders...14 Exhibit 26 The Introduction of 282

Diphtheria-Tetanus-Pert15 ussis and Oral Polio

Vaccine Among Young16 Infants in an Urban

African Community: A17 Natural Experiment18 Exhibit 27 Adverse Events 288

Associated with19 Childhood Vaccines:

Evidence Bearing on20 Causality21 Exhibit 28 Adverse Effects of 289

Vaccines: Evidence and22 Causality23 Exhibit 29 In Vivo Absorption of 296

Aluminum-Containing24 Vaccine Adjuvants Using

26AL25


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2 EXHIBIT INDEX3 NAME DESCRIPTION PAGE4 Exhibit 30 Aluminum Hydroxide 297

Injections Lead to5 Motor Deficits and

Motor Neuron6 Degeneration7 Exhibit 31 Delivery of 299

Nanoparticles to Brain8 Metastases of Breast

Cancer Using a Cellular9 Trojan Horse

10 Exhibit 32 Slow CCL2-Dependent 299 Translocation of

11 Biopersistent Particles from Muscle to Brain

12

Exhibit 33 Highly Delayed Systemic 29913 Translocation of

Aluminum-Based Adjuvant14 in CD1 Mice Following

Intramuscular15 Injections16 Exhibit 34 Non-Linear 301

Dose-Response of17 Aluminum Hydroxide

Adjuvant Particles:18 Selective Low Dose

Neurotoxicity19

Exhibit 35 Book: The Immune 30220 System and the

Developing Brain21

Exhibit 36 6/24/17 Letter to 30522 University of British

Columbia by Dr. Shaw23 with Attachments24 Exhibit 37 6/15/17 Letter to 308

InstitutMondor25


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2 EXHIBIT INDEX3 NAME DESCRIPTION PAGE4 Exhibit 38 6/15/17 Letter to The 308

Birchall Centre5

Exhibit 39 Aluminium in Brain 3096 Tissue in Autism7 Exhibit 40 Vaccine Excipient & 317

Media Summary8

Exhibit 41 Proceedings of the 3409 Society of Experimental

Biology and Medicine10

Exhibit 42 Attenuation of RA 27/3 34811 Rubella Virus in WI-38

Human Diploid Cells12

Exhibit 43 The New England Journal 34913 of Medicine, Vol. 289,

No. 1114

Exhibit 44 Untruths and 36615 Consequences: The

False Hypothesis16 Linking CHAT Type 1

Polio Vaccination to17 the Origin of Human

Immunodeficiency Virus18

Exhibit 45 Postscript Relating to 36619 New Allegations Made by

Edward Hooper at The20 Royal Society

Discussion Meeting on21 11 September 200022 Exhibit 46 VAERS Results 38823 Exhibit 47 Electronic Support for 391

Public Health - VAERS -24 12/1/07 - 9/30/1025


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2 EXHIBIT INDEX

3 NAME DESCRIPTION PAGE

4 Exhibit 48 VAERS Results 397

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8 REQUESTS FOR PRODUCTION

9 Page/Line

10 17/25 145/15

39/19 155/13

11 60/14 159/16

66/25 176/14

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1 Stanley Plotkin, M.D.

2 MS. NIEUSMA: I'm going to ask that

3 everybody speak up. You're all coming across a

4 little soft other than Maureen. She's doing

5 fine.

6 VIDEO OPERATOR: This is the start of

7 media labeled number one of the video-recorded

8 deposition of Dr. Stanley Plotkin in the matter

9 of Lori Matheson, formerly known as Lori Ann

10 Schmitt, versus Michael Schmitt, filed in the

11 State of Michigan, Circuit Court, County of

12 Oakland, Family Division.

13 This deposition is being held at

14 5833 Lower York Road in New Hope, Pennsylvania,

15 on January 11, 2018. My name is Tom Liebman,

16 and I'm the legal video specialist for the

17 TSG Reporting, Incorporated, headquartered at

18 747 Third Avenue in New York City. The court

19 reporter is Maureen Broderick, in association

20 with TSG Reporting.

21 Counsel, please introduce yourselves for

22 the record.

23 MR. SIRI: Aaron Siri, co-counsel on

24 behalf of plaintiff.

25 MS. RUBY: Amy Ruby, on behalf --


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2 co-counsel on behalf of plaintiff.

3 MS. NIEUSMA: Laura Nieusma, counsel for

4 defendant, Michael Schmitt.

5 VIDEO OPERATOR: The court reporter will

6 now swear in the witness.

7 - - -

8 STANLEY PLOTKIN, M.D., having

9 been first duly sworn to tell

10 the truth, was examined and

11 testified as follows:

12 - - -

13 EXAMINATION

14 - - -

15 BY MR. SIRI:

16 Q Good morning, Dr. Plotkin.

17 MS. RUBY: Can we just make a record under

18 this...

19 I would just like to clarify that this is

20 being recorded by a video deposition pursuant

21 to MCR 2.315.

22 BY MR. SIRI:

23 Q Good morning. Can you please state your

24 full name for the record.

25 A Stanley A. Plotkin.


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2 Q Dr. Plotkin, have you been deposed before?

3 A A long time ago. Many years ago.

4 Q In what matter was that?

5 A Oh, it had to do with an abortion done

6 because of congenital rubella.

7 Q What year approximately?

8 A The 1960s.

9 Q And what was your testimony about?

10 A My testimony was about the abnormalities

11 that occur in infants of women born -- that is,

12 infants of women who have congenital, who have

13 rubella during pregnancy and whose fetuses are

14 frequently affected with considerable congenital

15 abnormalities.

16 Q From rubella?

17 A From rubella.

18 Q Did that involve a vaccine?

19 A I, at the time I was developing a vaccine

20 against rubella; yes.

21 Q Have you been deposed in any other case?

22 A Not that I can recall, no.

23 Q Have you ever been an expert witness in

24 any lawsuit other than this one?

25 A Again, not for many years. I believe I


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2 did a couple of those cases in the '60s, but I have

3 avoided depositions since then.

4 Q Why is that?

5 A Because I consider that they seldom bring

6 out all the facts, but I'm willing to help in this

7 case.

8 Q I'm going to go over a few rules with you

9 for this deposition.

10 A Mm-hmm.

11 Q The court reporter has placed you under

12 oath. Same as a court of law, you're testifying

13 under penalty of perjury.

14 A Mm-hmm.

15 Q The court reporter's making a record and

16 will take down the questions that I ask and the

17 answers that you provide.

18 A Mm-hmm.

19 Q If you don't understand a question, let me

20 know before answering. Okay?

21 The court reporter can't take down

22 nods. That's another rule. So if you --

23 A Yes.

24 Q Anytime you want to vocalize, please wait

25 until I complete asking a given question, even if


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2 you think you know the answer, so that we have a

3 complete record, please.

4 As I -- don't speculate. If you

5 don't know the answer, then so state. But you

6 should provide your best recollection, even if it's

7 vague or partial. Okay?

8 A Yes.

9 Q Are you taking any medications or are

10 under the influence of any substance that might

11 affect your ability to testify today?

12 A I don't think so, no.

13 Q Is that no?

14 A No.

15 Q Okay. Did you discuss this deposition

16 with anyone?

17 A Actually, no. I've had some conversations

18 with Laura Nieusma, but not about the substance of

19 my testimony.

20 Q Before today, did you have any discussions

21 with anyone related to this deposition?

22 A No. Actually, I know very little about

23 the issue here. I understand that there's a

24 disagreement between parents, but that's all I

25 really know.


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2 Q And you haven't discussed this lawsuit

3 with anyone apart from opposing counsel?

4 A No.

5 Q How did you first learn about this

6 lawsuit?

7 A It was from a lady by the name of Karen

8 Ernst, who was the head of an organization called

9 Voices for Vaccines, which is a group of laypeople

10 who are favorable to vaccination. And she had heard

11 from the father, I believe, who was looking for

12 experts to testify on his behalf.

13 Q So you discussed this lawsuit with her?

14 A Not really discussed the lawsuit. She

15 referred me to the father, and I sent an email

16 saying that I would be willing to testify. I have

17 not talked to the father. I've never met the

18 father. So I, everything has happened secondhand,

19 so to speak.

20 Q And it was Karen Ernst who asked you to be

21 an expert in this case?

22 A She asked me if I would be willing, yes.

23 Q How many discussions have you had with

24 her?

25 A No discussions.


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2 Q About this case.

3 A About this case, simply had an email

4 exchange asking me to do it.

5 Q I'm going to request a copy of that email

6 chain, okay, Dr. Plotkin?

7 A If I can find it, I'll be glad to send it

8 to you.

9 Q Thank you.

10 So before today, other than speaking

11 with opposing counsel and an email communication

12 with Karen Ernst, you have not discussed this

13 lawsuit, this deposition, or the role that you'd be

14 playing here today with anybody else; is that right?

15 A I've had an email exchange with Paul

16 Offit, Dr. Paul Offit, who is actually a former

17 student of mine.

18 Q Who is Dr. Offit?

19 A Dr. Offit is a pediatrician at the

20 Children's Hospital of Philadelphia.

21 Q What did you discuss with Dr. Offit?

22 A I discussed with him the issues or the

23 possible issues about refusal to vaccinate.

24 Q What was the substance of those

25 discussions?


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2 A The substance basically concerned what

3 arguments are often used to oppose vaccination.

4 Q What are those arguments?

5 A The arguments generally are that vaccines

6 can cause reactions and that the reactions are worse

7 than the disease.

8 Q And what did Dr. Offit have to say about

9 that?

10 A Well, he pointed out, of course -- and

11 he's the author of a chapter in my Vaccines book --

12 that the opposite is true, that the disease is worse

13 than the reactions to the vaccines.

14 Q Do you have peer-reviewed science to

15 support that statement?

16 A Do I have what?

17 Q Peer-reviewed science to support that

18 statement?

19 A Yes, of course.

20 Q Would you be willing to provide that

21 science?

22 A Well, the science is in the chapter in my

23 textbook. But there are innumerable references,

24 some of which I have, but I can certainly provide

25 you with a list of references in the chapter.


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2 Q Great.

3 Have you reviewed any documents to

4 prepare for this deposition?

5 A You know, I've looked at the web. I don't

6 usually do that, but I've looked at the web, some of

7 the anti-vaccination websites.

8 Q Which of those sites did you look at?

9 A Oh, gosh. I can't give you the names.

10 I've just sort of scanned through a number of them.

11 Q Do you remember the names of any of them?

12 A Let's see.

13 MS. NIEUSMA: Dr. Plotkin, just to be

14 clear, if you don't remember something, just

15 say you don't remember and you can move on from

16 there.

17 THE WITNESS: Yeah. Well, here's one

18 called VaxTruth: Everything you ever needed to

19 know about medical exemptions to vaccination

20 but didn't know to ask.

21 There are a couple of others that I looked

22 at, many of which were appalling.

23 BY MR. SIRI:

24 Q Why do you believe they're appalling?

25 A Because they're ignorant of the facts,


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2 exaggerations, half-truths, or even misconceptions.

3 Q VaxTruth, does that website, is that a

4 website that catalogs personal stories of families

5 who believe their child was injured by vaccines?

6 A You know, I did not -- what shall I

7 say? -- read these word for word. I imagine that

8 that's the case, but I couldn't tell you

9 specifically about which website says what.

10 Q But you found VaxTruth appalling?

11 A Yes.

12 Q Other than reviewing the, what you refer

13 to as anti-vax or websites, did you review any other

14 documents to prepare for this deposition?

15 A Yes. I looked at a number of vaccine

16 safety studies, which, again, are referenced in the

17 vaccine safety chapter.

18 Q And apart from that, anything else?

19 A No.

20 Q Have you been provided any documents

21 related to this lawsuit?

22 A To whom?

23 Q Have you, Dr. Plotkin, been provided any

24 documents relating to this lawsuit specifically?

25 A No, I have not.


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2 Q Have you reviewed any medical records

3 related to this case?

4 A Medical records? No.

5 Q Have you done anything other than what

6 we've already discussed to prepare for this

7 deposition today?

8 A No. Basically, no.

9 Q Have you discussed the child at issue in

10 this case?

11 A No.

12 Q So you don't know anything specific about

13 the child at issue in this case, correct?

14 A I do not.

15 Q You don't know anything about her medical

16 history, correct?

17 A Correct.

18 Q And you don't know anything about her

19 family's medical history, correct?

20 A Correct.

21 Q Have you been on any trips in the last

22 year?

23 A Many.

24 Q Where to?

25 A Several trips to Europe, to France, to


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2 Germany.

3 Let's see. Have I been to Asia in

4 the last year? Yes. I've been to Japan.

5 Basically, I mean, of course, many trips in the

6 United States, England.

7 Q How many times --

8 A At least a dozen trips.

9 Q At least a dozen. How many times were you

10 in France in the last year?

11 A Oh, gosh. Twice, I think.

12 Q Germany?

13 A Once.

14 Q England?

15 A Once.

16 Q These are all separate trips?

17 A Yes.

18 Q In which you got on a plane from the

19 United States, flew there, flew back?

20 A Yes.

21 Q Japan, how many times?

22 A Once.

23 Q How many times to other countries outside

24 of U.S.?

25 A I've probably had about a dozen trips


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2 altogether. If I known that you were interested, I

3 would have brought my calendar.

4 Q How about trips in the United States that

5 required you to get on a plane, how many of those

6 would you say in the last year?

7 A Mainly to California. A lot of trips to

8 Washington. Boston.

9 Q California, Washington. Same city in

10 California each time or different?

11 A No. San Francisco, San Diego.

12 Q What were the purpose of most of these

13 trips?

14 A Attend meetings, scientific meetings.

15 Q Were any of them related to companies

16 developing vaccines?

17 A Oh, yes.

18 Q Would you say most of them were?

19 A Most of them? Probably about half of

20 them.

21 Q Do you have any, do you have any trips

22 planned for 2018?

23 A Yes.

24 Q Where to?

25 A I'll be going to India next month and,


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2 however, I'm trying to cut down on foreign trips.

3 So at the moment, I'll be going to Germany in June.

4 Aside from that, I'll be going to France in May. I

5 think that's all I can recall at the moment.

6 Q What's your trip to France for?

7 A I'll be teaching in an advanced

8 vaccinology course in Annecy.

9 Q Where?

10 A Annecy.

11 Q What's that? I'm sorry.

12 A A-N-N-E-C-Y. It's a town in France.

13 Q Who is sponsoring this course?

14 A Well, it's sponsored by the University of

15 Geneva and the Gates Foundation.

16 Q Anybody else?

17 A No. Basically those are the funders.

18 Q And your trip to Germany, what's that for,

19 Doctor?

20 A I'll be going to visit a biotechnology

21 company that is trying to develop vaccines based on

22 RNA.

23 Q Do you have a position or affiliation with

24 that company?

25 A I'm simply on their scientific Board.


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2 Q And your trip to India, purpose of that

3 one?

4 A To discuss vaccination against

5 chikungunya, a virus which is epidemic in India and

6 in South America.

7 Q And who are those discussions with?

8 A Well, it's under the aegis of an

9 organization called CEPI, which is a coalition to

10 develop vaccines against epidemic diseases. So it's

11 an organization that's received funding from various

12 governments to meet the challenges of epidemic

13 diseases like Ebola and chikungunya, et cetera.

14 Q This trip also include meeting with

15 vaccine developers?

16 A Well, they will be present at the meeting.

17 They will come and present the results of their

18 efforts to develop a vaccine against chikungunya.

19 Q Any trips planned in the United States for

20 2018?

21 A Wish I had known to bring my calendar. I

22 have no trips planned this month or actually next

23 month. But I will be going to some NIH-sponsored

24 meetings in March, as I recall, and there's a

25 vaccine conference in Washington in April that I'll


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2 be going to.

3 MS. NIEUSMA: When you say "Washington,"

4 do you mean Washington state or District of

5 Columbia?

6 THE WITNESS: District of Columbia.

7 In May I'll be going back to France for

8 the advanced vaccinology course. That's as

9 much as I can remember at the moment.

10 BY MR. SIRI:

11 Q Okay. There might be others; you just

12 don't have your calendar here today, right?

13 A Right.

14 Q And the NIH meetings, where are those

15 taking place?

16 A In Bethesda.

17 Q How far is that from here?

18 A From here?

19 Q Yeah. Do you drive there?

20 A Oh, no. I take the train to Washington

21 and then the Metro to Bethesda.

22 Q How long does that trip take?

23 A The train is an hour and a half. Metro is

24 maybe 20 minutes.

25 Q What's the name of the plaintiff in this


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2 case?

3 A Well, from what was said before, the

4 plaintiff, I think, is someone named Schmitt. I've

5 not followed -- as I've said before, I have not been

6 involved in the legal details. So I don't know the

7 names except from what I've heard.

8 Q What's the name of the defendant in this

9 case?

10 A As I understand it, they're a married

11 couple, but that's all I can tell you. So I presume

12 they're both named Schmitt.

13 Q What's the name of their child?

14 A I do not know.

15 Q How old is their child?

16 A I do not know.

17 Q Do you know whether the child has received

18 any vaccines?

19 A I do not know.

20 Q The name of the child is Faith. I'll

21 refer to the child as Faith during this deposition,

22 okay?

23 A Mm-hmm.

24 Q Faith's father believes that Faith's

25 mother was wrong to not have given Faith all


Page 27


2 CDC-recommended vaccines on time.

3 Do you agree with the father?

4 A Yes.

5 Q Is it your understanding that the father

6 wants Faith to receive all vaccines she has missed

7 and continue to receive all CDC-recommended

8 vaccines?

9 A That is my understanding, yes.

10 Q Do you agree with the father that Faith

11 should receive these vaccines?

12 A Absent any contraindication, yes.

13 Q Sitting here today, do you know whether

14 Faith has any contraindications?

15 A I do not know.

16 Q So sitting here today, you don't know

17 whether Faith should or should not actually get

18 these vaccines?

19 A In the absence of a contraindication,

20 Faith should receive the vaccines.

21 Q But you don't know whether she has a

22 contraindication?

23 A I do not know the medical history of the

24 child.

25 Q What vaccines has Faith missed according


Page 28


2 to the CDC schedule that you believe she should get?

3 A Well, the CDC's schedule includes the

4 diphtheria, tetanus, pertussis, hepatitis B,

5 haemophilus influenzae, polio, measles, mumps,

6 rubella.

7 I don't know how old she is, so I

8 don't know, you know, where to stop. But there are

9 vaccines recommended in preadolescents. So she

10 should receive those when she reaches the

11 appropriate age.

12 Q So just so I got -- just to make sure I

13 understand, you believe she should get the

14 hepatitis B vaccine?

15 A Yes.

16 Q Rotavirus?

17 A Yes.

18 Q DTaP?

19 A Yes.

20 Q Hib?

21 A Yes.

22 Q PCV13?

23 A Yes.

24 Q IPV?

25 A Yes.


Page 29


2 Q The flu shot annually?

3 A Yes.

4 Q IIV, we'll call it the flu shot?

5 A At the moment, yes.

6 Q I'm sorry. At the moment?

7 A At the moment.

8 Q What do you mean?

9 A I mean that there are two influenza

10 vaccines, one of which is recommended for this year;

11 the other is not recommended at the moment but may

12 be in the future.

13 Q You think she should get the recommended

14 one?

15 A Yes.

16 Q And you think she should get the MMR, I

17 believe you said?

18 A Yes. And varicella.

19 Q And hepatitis A vaccine?

20 A I'm sorry.

21 Q And hep A vaccine?

22 A And the hep A vaccine, yes.

23 Q How many doses of hep B as a child do you

24 recommend they receive?

25 A Three.


Page 30


2 Q How many doses of rotavirus do you

3 recommend?

4 A Two or three.

5 Q And you recommend Faith receive those,

6 right?

7 A Yes.

8 Q And you recommend that she receive the

9 three doses of hep B?

10 A Yes.

11 Q And how many doses of DTaP do you

12 recommend she receive?

13 A Well, currently at least three, then a

14 booster and eventually another booster.

15 Q How many doses of Hib do you recommend she

16 receive?

17 A Well, three are usually sufficient.

18 Q How many doses of PCV13?

19 A Three.

20 Q And how many doses of IPV or an

21 inactivated polio vaccine?

22 A Three.

23 Q How many doses of the flu shot?

24 A Well, one per year.

25 Q And how many doses of MMR?


Page 31


2 A At least two, yes.

3 Q How many doses of varicella?

4 A Two.

5 Q And hep A?

6 A Two or three. Two is often sufficient.

7 Q And those are the doses that you recommend

8 that Faith receive, correct?

9 A Yes.

10 Q For each of those vaccines we just went

11 through?

12 A Yes.

13 And then there are the adolescent

14 vaccines as well.

15 Q And what are those?

16 A Well, meningococcus is often recommended

17 and also human papillomavirus vaccine to, especially

18 if she is a girl, but it's also recommended for boys

19 as well.

20 Q And you recommend that Faith receive those

21 as well as meningococcus and HPV vaccine?

22 A Yes.

23 Q Any others?

24 A Well, I could look up the vaccine

25 schedule, if you wish me to, but I am sure that I


Page 32


2 agree with all of the CDC recommendations.

3 Q How about when she becomes an adult; would

4 you recommend that she get all of the adult vaccines

5 that are recommended by the CDC for adults?

6 A Certainly, yes.

7 Q What are the, can you please tell me the

8 brand name and manufacturer for each of the hep B

9 vaccines?

10 A I do not try to memorize brand names. As

11 I recall, Engerix is the most commonly used

12 hepatitis B vaccine, which is manufactured by

13 GlaxoSmithKline. There's also a vaccine

14 manufactured by Merck. I don't remember the trade

15 name at the moment. As I said, I don't try to

16 memorize trade names.

17 Q So for the hepatitis B, there's a vaccine

18 manufactured by GlaxoSmithKline. Can we refer to

19 that either as Glaxo or GSK today?

20 A Mm-hmm. Yes.

21 Q And there's one manufactured by Merck?

22 A Correct.

23 Q Rotavirus, what are the brand names and

24 companies that manufacture those?

25 A Well, actually, one of the rotavirus


Page 33


2 vaccines I developed, so I do know that the trade

3 name is called RotaTeq. And the other one is called

4 Rotarix.

5 Q Who manufactured those?

6 A I'm sorry.

7 Q Who sells those, manufactures those?

8 A Merck manufactures RotaTeq, and GSK

9 manufactures Rotarix.

10 Q How about DTaP, who -- what are the brand

11 names or manufacturers for DTaP?

12 A Oh, boy. Sanofi Pasteur manufactures

13 DTaP, and so does GSK. I do not remember the trade

14 names.

15 Q How about the hepatitis B vaccine; can you

16 tell me what are the brand names for those products

17 and the manufacturer?

18 A For hepatitis B?

19 Q For Hib. I'm sorry.

20 A For Hib?

21 Q I apologize. Did I say hep B? I meant

22 Hib. Which stands for what, by the way,

23 Dr. Plotkin?

24 A Haemophilus influenzae type B.

25 Q Thank you. So --


Page 34


2 A Well, again, my recollection is that

3 Sanofi and GSK, yes, both manufacture Hib.

4 Q And -- okay. And what about PCV13; what

5 is the name of the product and the manufacturer of

6 that vaccine?

7 A I don't remember the trade name, but

8 Pfizer is the manufacturer.

9 Q What about the flu shot?

10 A Oh, well, there are multiple

11 manufacturers.

12 Q Yes, there are multiple manufacturers of

13 the shot. Let's, in terms of flu shots -- strike

14 that.

15 We're going to come back to the flu

16 shot. We'll make it simple.

17 Well, let me ask you this, actually,

18 about the flu shot: What flu shots, are there any

19 flu shots recommended for children under one year of

20 age?

21 A No. Six months usually is the time, the

22 age at which influenza vaccines are recommended for

23 children.

24 Q Do you know who manufactures flu shots

25 recommended for children under one year --


Page 35


2 A For children?

3 Q Yeah.

4 A I don't remember which of the

5 manufacturers. There are probably ten different

6 influenza vaccines, not all of which have been

7 tested in children.

8 So there are relatively few for

9 children, all of them manufactured in a chick

10 embryo. But anyway, I don't -- I'm sure that the

11 major manufacturers like Sanofi and GSK certainly

12 manufacture influenza vaccines.

13 There's an Australian manufacturer,

14 CSL.

15 Q But, I mean just for -- I'm sorry,

16 Dr. Plotkin. Just for, by age group, do you -- let

17 me make this simpler.

18 Do you know, do you have a

19 recollection of which flu shots are recommended for

20 which age groups?

21 A You mean which manufacturers?

22 Q Right.

23 A I don't, don't recollect.

24 Q In terms of the, in terms of the IPV, the

25 inactivated polio vaccine, who manufactures, what is


Page 36


2 the product name manufacturer for that?

3 A I don't remember the trade name, but

4 Sanofi and GSK both make IPV.

5 Q And the MMR vaccine, what is the product

6 name and manufacturer for that one?

7 A Merck is the manufacturer. GSK also makes

8 one, but Merck is pretty much the American

9 manufacturer for MMR.

10 Q And for varicella, the product name and

11 manufacturer?

12 A Well, Merck, again, manufactures varicella

13 vaccine, and GSK also does.

14 Q And then for the hepatitis A vaccine, who

15 is the, what are the product names and

16 manufacturers?

17 A Hepatitis A, GSK is the biggest

18 manufacturer of hepatitis A.

19 Q Is there any -- got it. Okay. And

20 then...

21 How about the meningococcal vaccine;

22 what's the product name and manufacturer for that

23 one?

24 A Meningococcal vaccines are manufactured at

25 the present time by Sanofi, by GSK, by Pfizer.


Page 37


2 Those are the three.

3 Q And how about the HPV vaccine

4 manufacturer, the product name and manufacturer,

5 please?

6 A Merck and GSK both manufacture HPV

7 vaccines.

8 Q So every vaccine that you believe Faith

9 should receive is produced by either Merck, Sanofi,

10 GSK, or Pfizer, correct?

11 A Yeah. That's pretty much the case. In

12 this country, at the present time, there are a

13 limited number of vaccine manufacturers because

14 vaccine manufacture is difficult and costly.

15 Q Would it be correct to call these four

16 companies the big four vaccine manufacturers?

17 A Yes, that's correct. Johnson & Johnson is

18 attempting to come into the field, but they are not

19 yet one of the major manufacturers.

20 Q Have you received any payments from Sanofi

21 or any of its related or predecessor entities?

22 A Yes. Certainly.

23 Q In what years did you receive payments?

24 A Oh, geez. Well, first of all, as you

25 should know, in the 1990s I was medical and


Page 38


2 scientific director of Sanofi Pasteur, and so

3 obviously I was paid by them.

4 And since then I've been consulting

5 for manufacturers, for biotechs, for governments,

6 for nonprofits, and essentially for anyone

7 interested in vaccine development.

8 And so I have been remunerated by

9 companies, not by nonprofits, obviously, and that is

10 essentially what I do.

11 Q Is there a year since 1990 that you've not

12 received any kind of payment or remuneration from

13 Sanofi?

14 A Probably not, no.

15 Q How much did you receive -- what would you

16 say is approximate total amount of payments and

17 remunerations you've received from Sanofi during

18 your lifetime?

19 A Oh, my God. I have no idea. I'm sure

20 it's a sizable amount of money. But I, you'd have

21 to ask my wife, who's essentially my accountant.

22 Q Is your wife the person that would have

23 the records to know that amount?

24 A Yeah. She probably would.

25 Q Okay. Would you say it's more or less


Page 39


2 than a hundred thousand dollars?

3 A Oh, I'm sure it's more than that.

4 Q Would you say it's more or less than

5 500,000?

6 A Probably, yes. Over the years, I imagine

7 it is.

8 Q Would you say it's more or less than a

9 million dollars?

10 A Well, again, I'm not prepared to answer

11 this question, but I'm sure it's a considerable

12 amount of money. And over the years, it could well

13 be more than a million.

14 Q Do you believe it could be a few million?

15 A You know, Counselor, I cannot give you a

16 precise figure. It is a considerable amount of

17 money. I do not doubt. But I could not give you a

18 specific number because I've never looked at it.

19 Q I'm going to make a request for the

20 documents to understand precisely how much you've

21 received from Sanofi over the years.

22 MS. NIEUSMA: I mean, you guys can do any

23 discovery requests that you want. If he

24 doesn't have it with him today, he can't

25 produce it right now.


Page 40


2 MR. SIRI: Your objection is noted,

3 Counsel. Thank you.

4 BY MR. SIRI:

5 Q Has any entity in which you directly or

6 indirectly have a greater than 1 percent ownership

7 interest received any payment from Sanofi or any of

8 its related or predecessor entities?

9 A Could you repeat that question.

10 Q Sure. Does any entity -- do you

11 understand what I mean by the term "entity,"

12 Dr. Plotkin?

13 A Are you talking about me personally or --

14 Q When I say, I'm asking if you understand

15 what the term "entity" means in that question.

16 A No.

17 Q Okay. Great.

18 So when I use the term "entity," I

19 mean it to include any business, sole

20 proprietorship, company, LLC, LLP, limited liability

21 company, organization, and so forth. Is that clear

22 what "entity" means?

23 A Yeah.

24 Q So what I'm asking, has any entity, so any

25 business company, that you've had directly or


Page 41


2 indirectly more than 1 percent ownership interest,

3 okay, has any company like that received money from

4 Sanofi?

5 A Well, again, I'm not sure I understand the

6 question. But I am the principal of a company

7 called Vaxconsult --

8 Q Okay.

9 A -- which essentially was organized to make

10 things easier from the tax point of view. And that

11 entity, if that's what you mean, has received

12 payments from companies for whom I consult.

13 So it's a device, if you will, to

14 make things simpler for the accountant.

15 Q Okay. So who owns Vaxconsult?

16 A I do -- well, my wife and I do.

17 Q And what percent do you own?

18 A A hundred percent.

19 Q Okay. And is there any other company --

20 and payments have been made to Vaxconsult by Sanofi?

21 A Sure.

22 Q And what's the total amount of payments

23 that have been made to Vaxconsult by Sanofi?

24 A Well, again, I do not have an exact

25 number. I am sure that over the years, it's a


Page 42


2 considerable amount, but I cannot tell you exactly

3 how much.

4 Q Is there any other company in which you

5 have an ownership interest that's received money

6 from Sanofi?

7 A No.

8 Q You anticipate to continue to receive

9 payments or any kind of other remuneration from

10 Sanofi in the future?

11 A As long as my health holds out, yes.

12 Q What are those payments for?

13 A For advice.

14 Q Have you received any payments from Merck

15 or any of its related or predecessor entities?

16 A Yes.

17 Q What year did you receive payments?

18 A All I can say is since I stopped working

19 for Sanofi, which was in early 2000s, I've consulted

20 for essentially all of the major manufacturers. I

21 do not know how much I received. But I have

22 certainly received payments from Merck, from Glaxo,

23 from Pfizer, and many other entities.

24 Q So what was approximately the first year

25 that you received payments from Merck?


Page 43


2 A Sometime in the 2000s.

3 Q Would you say that you've received more

4 than a hundred thousand dollars in

5 payments/remuneration from Merck since then?

6 A I have no idea.

7 Q But you would have records that would be

8 able to determine that amount, correct?

9 A Yes. I doubt -- actually, I doubt that

10 it's a hundred thousand, but I don't, I don't

11 recall. As I said, my wife does the accounting, and

12 I pay no attention to it.

13 Q Do you anticipate receiving any payments

14 or remuneration from Merck in the future?

15 A Sure.

16 Q You said that you received payments and

17 other remuneration from GSK in the past?

18 A Yes.

19 Q When did those payments start?

20 A Again, I cannot give you a precise year.

21 But as I've tried to say repeatedly, since 2000,

22 I've been consulting for many different entities,

23 including GSK and the others.

24 Q Do you expect to continue to receive

25 payments or remuneration from GSK in the future?


Page 44


2 A Yes.

3 Q I'll ask you the same question about

4 Pfizer. You indicated that you have received

5 payments or remuneration from Pfizer?

6 A Yes.

7 Q Do you remember when you first received

8 any payments from them or any remuneration?

9 A No, I don't recall what year that would

10 be.

11 Q And do you have a sense of approximately

12 how much you've received?

13 A No.

14 Q Do you anticipate continuing to receive

15 payments or remuneration from Pfizer?

16 A Very likely.

17 Q Now, all of the payments you've received

18 from the big four vaccine manufacturers, as we've

19 defined it, they were either made to you directly or

20 through Vax -- I'm sorry. What was the --

21 A Vaxconsult.

22 Q Or Vaxconsult?

23 A Yes.

24 Q Why don't we try this a little bit of a

25 different way. Since it appears your memory of --


Page 45


2 over longer periods of time is not as clear with

3 regard to how much payment or remuneration you

4 received from the big four, can you tell me, what is

5 the total amount of payments in dollars you received

6 in 2017, last year, from anyone or any entity

7 involved in the development or sale of vaccines?

8 A Of what?

9 Q From any entity involved in the

10 development or sale of vaccines.

11 A Oh, my recollection is in the neighborhood

12 of 200,000.

13 MR. SIRI: Sorry about that. My

14 microphone wire got stuck. Let me just get

15 this back on.

16 BY MR. SIRI:

17 Q Do you own any stock in Sanofi?

18 A No.

19 Q Have you ever?

20 A No.

21 Q Do you own any stock options in Sanofi?

22 A No.

23 Q Have you ever?

24 A No.

25 Q How about from Merck, Glaxo, or Pfizer; do


Page 46


2 you own any stock in any of those companies?

3 A No.

4 Q Any stock options?

5 A No.

6 Q Has any educational or not-for-profit

7 institution in which you have been involved received

8 funding from Sanofi?

9 A That's a very difficult question to

10 answer. I don't inquire about the finances of the

11 organizations that I work for or that I advise. So

12 I find that question very difficult to answer.

13 I imagine that some of them do, but I

14 have no knowledge of the matter. Voices for

15 Vaccines, for example, receives no funding from any

16 of the pharmaceutical companies, and that is in

17 order to avoid any suggestion of a conflict of

18 interest. I think that's probably true for a number

19 of the nonprofits I advise. But obviously it may

20 not be true for companies.

21 Q So you're saying Voices for Vaccines

22 doesn't receive any funding from pharmaceutical

23 companies?

24 A None.

25 Q What's your affiliation with that group?


Page 47


2 A Well, I was one of those who suggested

3 that an organization of laypeople, as opposed to

4 scientists, would be a good idea to oppose all of

5 the nonsense that one sees on the web from

6 anti-vaccination organizations.

7 Q So it was your idea to create Voices for

8 Vaccines?

9 A It wasn't my sole idea. It was a

10 suggestion that I made at a certain point. And it

11 turned out that there were laypeople who were

12 interested in promoting vaccines. Since then I've

13 been on their advisory Board. But other than that,

14 I have no role in the organization.

15 Q But you were, from what I'm understanding,

16 tell me if I'm correct, it sounds like you were a

17 driving force in suggesting its creation and at

18 least initially --

19 A Yes.

20 Q -- getting it set up; is that correct?

21 A Yes. Mm-hmm.

22 Q I'm going to hand you what has been marked

23 as Plaintiff's Exhibit 1.

24 (Exhibit Plaintiff-1 was marked

25 for identification.)


Page 48


2 MS. NIEUSMA: Amy, is that coming to my

3 email?

4 MS. RUBY: It will be in just one moment.

5 MS. NIEUSMA: All right.

6 BY MR. SIRI:

7 Q I'm going to hand you what's been marked


9 MS. RUBY: It's been sent. Hopefully it

10 will come through.

11 MS. NIEUSMA: I'm sure it will.

12 Got it.

13 MR. SIRI: Okay. Great.

14 BY MR. SIRI:

15 Q Dr. Plotkin, do you recognize this as a

16 printout from the Voices for Vaccines website?

17 A Well, that's what it says. I don't read

18 the website that often, but yes.

19 Q Okay. And I see that it's got you listed

20 on the scientific advisory Board --

21 A Yes.

22 Q -- on the third page, correct?

23 A Yes.

24 Q Now, you see at the very end on the last

25 page, Dr. Plotkin, see at the very bottom it says:


Page 49


2 Voices for Vaccines is an administrative product of

3 the Task Force for Global Health?

4 A Yes.

5 Q And it receives funding from that

6 organization, correct?

7 A No. It does not receive funding. The

8 task force was asked to do the -- what shall I

9 say? -- the financial stuff required for an

10 organization like Voices for Vaccines. But it does

11 not contribute financially to Voices for Vaccines.

12 Q Dr. Plotkin, I'm going to hand you what's

13 been marked as Exhibit 2. This is a form 990 tax

14 return for the Task Force for Global Health.

15 MR. SIRI: I'm not going to ask him

16 questions until you've emailed it.



19 BY MR. SIRI:

20 Q So I've handed you what has been marked as

21 Plaintiff's Exhibit 2. It is the tax return for,

22 the 990 tax return for the Task Force for Global

23 Health. If you turn to the second page, do you see

24 Section 4C?

25 A Yes.


Page 50


2 Q Where there's expenses of $3,757,924?

3 A Yes.

4 Q Do you see that one of the groups

5 receiving part of that funding was, in the last

6 line, Voices for Vaccines?

7 A I don't see where it says --

8 Q Last sentence in 4C.

9 A Voices for Vaccines is expanding its

10 educational outreach through new media and parenting

11 networks, increasing its membership and its

12 on-the-ground reach.

13 So?

14 Q If you go up to number four, Dr. Plotkin.

15 Can you read what the items in that list are

16 supposed to be describing?

17 A Expenses, including grants, revenues.

18 So?

19 Q I'll read to it you, number four. It

20 says, number four says: Describe the organization's

21 programs, service, accomplishments for each of its

22 three largest program services as measured by

23 expenses.

24 A Yeah.

25 Q Are you claiming that this document does


Page 51


2 not represent that Voices for Vaccines received

3 funding from the Task Force for Global Health?

4 A As far as I am aware, that the Voices for

5 Vaccines receives no funding from the task force.

6 The task force under Dr. Alan Hinman has agreed to

7 do the financial, whatever is required by the

8 government to do the financial work, for Voices for

9 Vaccines.

10 But as far as I'm aware, it receives

11 no funding from the task force or any other

12 governmental or semi-governmental entity.

13 Q So the task force does provide some

14 support for Voices for Vaccines, correct?

15 A It does.

16 MS. NIEUSMA: He already answered. He

17 said he doesn't know.

18 MR. SIRI: Your objection is noted. Thank

19 you.

20 BY MR. SIRI:

21 Q The Task Force for Global Health, does the

22 Task Force for Global Health receive funding from

23 any of the big four pharmaceutical companies?

24 A I do not know for a fact, but I doubt it.

25 The task force, I know, secondhand. But I, I


Page 52


2 believe that they receive funding from CDC, but as

3 far as I know, not from companies.

4 Q Dr. Plotkin, I'm going hand you what's

5 been marked as Plaintiff's Exhibit 3.



8 THE WITNESS: Yeah. So?

9 BY MR. SIRI:

10 Q This is a --

11 A I see, yes, where it says: Funders.

12 Well, I stand corrected. So the task

13 force, then, does receive funding from companies.

14 However, I don't see that has any bearing on its

15 work for Voices for Vaccines.

16 MS. NIEUSMA: Where is that in the -- am I

17 looking at the same exhibit you guys are?

18 MS. RUBY: You should have received

19 Deposition Exhibit 3.

20 MS. NIEUSMA: It's a page from The Lancet?

21 MR. SIRI: No. Number 80. No. That's

22 the wrong one.

23 MS. RUBY: Give me one second. Sorry.


25 (Brief pause.)


Page 53


2 MR. SIRI: Counsel --

3 MS. NIEUSMA: Yes.

4 MR. SIRI: What it is, it's a fact sheet

5 printed out from the Task Force for Global

6 Health, and on the left side it just shows the

7 donors.

8 MS. NIEUSMA: Okay.

9 MR. SIRI: Dr. Plotkin's already, he's

10 already -- I'm just going to ask him to read

11 the donors and that's it.

12 I assume --


14 BY MR. SIRI:

15 Q So does this show that the Task Force for

16 Global Health received funding from GSK?

17 A Yes, it does. But I want to repeat that

18 the Voices for Vaccines has studiously avoided

19 receiving funding from any company. And the fact

20 that the task force is doing its finances was only a

21 matter of convenience and an offer from Dr. Hinman

22 that they would do that because they have experience

23 with filing tax returns, et cetera.

24 And I do not believe, and I strongly

25 do not believe that any of the funding to the task


Page 54


2 force passes to Voices for Vaccines.

3 Q Does the Task Force for Global Health

4 receive funding from Merck?

5 A Yes.

6 Q And from Pfizer?

7 A Apparently, yes.

8 Q So the Task Force of Global Health

9 receives funding from pharmaceutical companies. And

10 at the least, I'm understanding from you, provides

11 some kind of administrative support services to the

12 Voices for Vaccines, correct?

13 A Correct.

14 Q And one of the founding voices to create

15 that organization was yourself, correct?

16 A I was one of those who suggested it, yes.

17 Q And you received remuneration from

18 pharmaceutical companies, correct?

19 A I do, yes.

20 Q Does anybody that works for Voices for

21 Vaccines -- strike that.

22 Going back to what we were

23 discussing, I had asked you earlier, has any

24 educational or non-for-profit institution in which

25 you have been involved received funding from Sanofi?


Page 55


2 And you indicated that would be

3 difficult to answer.

4 Can you tell me -- but you did

5 indicate to me, and correct me if I'm saying -- I

6 don't want to misspeak. But you indicated there are

7 some groups that don't receive any funding from

8 pharmaceutical companies, correct? And you

9 mentioned --

10 A Correct.

11 Q -- Voices for Vaccines as the main one?

12 A Yes.

13 Q Is there any other education or nonprofit

14 institution in which you've been affiliated that

15 you're aware of that does not and has not received

16 funding from any of the, any vaccine company?

17 A Well, I certainly advise the Gates

18 Foundation. I advise the National Institutes of

19 Health. I think those are the major institutions

20 that are not in the business of, in the business of

21 developing vaccines. And they do not receive

22 funding from companies.

23 Q Does the NIH hold any patents on any

24 vaccine-related technology?

25 A I believe they do, yes.


Page 56


2 Q Do they receive royalties from those

3 patents?

4 A I imagine they do, yes.

5 Q To your knowledge, you're not aware of

6 whether any of the other educational non-for-profit

7 institutions outside of Voices for Vaccines, as

8 you've said, Gates Foundation or NIH, that don't

9 receive any money from any of the pharmaceutical

10 companies?

11 A I'm not sure I can answer that question

12 categorically, but --

13 Q Just based on your knowledge. I mean,

14 either you, you know, if you don't know, then...

15 A I'm sure there are organizations that are

16 not funded by industry. But whether -- I'm trying

17 to think of ones that I've advised over the years.

18 Well, the Seidman Foundation. I'm

19 not sure whether they received funding from industry

20 or not. But I don't normally inquire of the

21 organizations that I advise where their funding

22 comes from.

23 Q Have you ever worked on developing a

24 vaccine that was eventually used by the public?

25 A Yes.


Page 57


2 Q Which ones?

3 A Let's see. Well, rubella, rotavirus,

4 rabies, and I made contributions here and there to

5 anthrax, cytomegalovirus, varicella. That's all I

6 can remember at the moment.

7 Q The varicella vaccine, you're talking

8 about VARIVAX?

9 A Yeah.

10 Q When you say you contributed to it, how

11 did you contribute to development of varicella?

12 A Essentially by showing how it could be

13 used and demonstrating that it was safe and

14 effective.

15 Q Did you work directly with Merck on that?

16 A I don't recall whether it was directly

17 with Merck or not. Certainly it was the vaccine

18 produced by Merck. But whether -- I don't recall

19 that they actually funded my studies of varicella

20 vaccine. But they were, they were the producers of

21 the vaccine, certainly.

22 Q Where were you working when you did this

23 work?

24 A At Children's Hospital of Philadelphia.

25 Q Did Children's Hospital ever acquire any


Page 58


2 intellectual property rights on what was --

3 A For varicella, no.

4 Q Have you developed or been part in any way

5 in the development of any vaccine from which you

6 have received any payment, revenue, or income

7 related to the sale of that vaccine?

8 A Yes. Although I should stipulate that all

9 of the patents on vaccines that I've developed have

10 been taken out by the institutions for which I was

11 working and that they gave me -- and I stress that

12 it was not a requirement, but they gave me part of

13 the profits deriving from the patents.

14 Q Which were those?

15 A Sorry?

16 Q Which vaccines are those?

17 A Mainly rubella, rotavirus, and rabies.

18 Q And the rubella vaccine that you developed

19 is currently used as part of the MMR vaccine?

20 A Correct.

21 Q And this is one of the vaccines you

22 believe Faith's pediatrician should purchase and

23 administer to her?

24 A Absolutely.

25 Q What is the total amount of payments in


Page 59


2 any form you have directly or indirectly received

3 from the sale of the rubella vaccine?

4 A I cannot give you a figure. I would say

5 that I do not doubt. But, again, I'd have to ask my

6 wife. I do not doubt that they were substantial

7 amounts of money, and similarly for rotavirus and

8 rabies.

9 Q Was it in the millions of dollars for

10 rubella? Just rubella.

11 A I don't think so. That's all I can say.

12 I don't think so.

13 Q Are you in the possession of documents

14 that would illuminate how much you've received in

15 payments from the sale of the rubella vaccine?

16 A Probably. I hope they have been retained.

17 I don't know. But I imagine.

18 Q And do you continue to receive any

19 payments from the sale or royalties or any other

20 remuneration from the sale of the rubella vaccine?

21 A Currently, I don't think so.

22 Q When did it cease?

23 A Oh, Jesus, I couldn't tell you exactly.

24 Sometime during this century. I don't know. You

25 know, if I had thought that this was going to be


Page 60


2 about my finances, I would have had my wife come

3 along because I don't follow these things. And

4 certainly what I've done has not been based on what

5 remuneration I could receive from the work that I've

6 done.

7 So if you want financial details, I

8 will have to collect them in some other form.

9 But --

10 Q How do you think your wife would feel of

11 you offering her up for a deposition?

12 A I don't think she would like it very much.

13 Q That wasn't a serious question.

14 MR. SIRI: Okay. I'll request those

15 documents.

16 BY MR. SIRI:

17 Q Now, do you have -- you said that you're

18 not sure whether it was in the millions of dollars

19 that you've received from the sale of rubella,

20 correct?

21 A Correct.

22 Q But it could have been?

23 A I doubt it, but it could have been. I

24 don't think so.

25 Q Who provided you those payments?


Page 61


2 A The Wistar Institute.

3 Q Did it come from any other source other

4 than Wistar?

5 A I don't think so because the Wistar holds

6 the patent.

7 Q Were you listed as one of the patent --

8 A One of the inventors?

9 Q One of the inventors?

10 A I believe so, yes.

11 Q But the Wistar was the assignee; is that

12 right?

13 A Yes.

14 Q And so they received the -- they're the

15 ones who had the, gave the license to Merck?

16 A Yes. Yes.

17 Q So Merck would pay Wistar, and then Wistar

18 would remit some of that to you; is that correct?

19 A That's correct. I'm trying to recall

20 whether Children's Hospital was involved. I don't

21 think so at that point because that was many years

22 ago.

23 Q And you indicated that you've also

24 developed the rotavirus vaccine earlier. I believe

25 you said it was RotaTeq?


Page 62


2 A Yes.

3 Q That's, and I think you said earlier

4 that's currently one of two rotavirus vaccines

5 currently on the market in the U.S.?

6 A Yes.

7 Q And you obtained a patent for RotaTeq?

8 A Wistar and Children's Hospital developed

9 patents.

10 Q Who is listed as the inventor or

11 co-inventors?

12 A Myself, Paul Offit and Fred Clark.

13 Q Who are the assignees of the patent for

14 RotaTeq?

15 A Assignees, you mean who used the --

16 Q Well, you know, when you file a patent,

17 there's usually an inventor listed and then there's

18 who you, the patent is assigned to.

19 A Well, the patents were taken out by Wistar

20 and Children's Hospital, if that's what you mean.

21 Q Okay. And so they were the ones who had

22 the rights to the patent?

23 A Yes.

24 Q How much remuneration to date have you

25 received from sales of RotaTeq?


Page 63


2 A I couldn't tell you exactly, but it's been

3 a considerable amount.

4 Q Has it been in the millions?

5 A I hesitate to say exactly. It could be,

6 but I really do not know.

7 Q You were entitled -- so you indicated that

8 Children's Hospital of Philadelphia, is that

9 sometimes referred to as CHOP?

10 A Yes.

11 Q CHOP was entitled to receive revenue from

12 the sale of RotaTeq?

13 A Yes.

14 Q What portion from the sale of RotaTeq was

15 CHOP entitled to?

16 A Well, as I understand it, 50 percent.

17 Q And what percent of that 50 were you

18 entitled to?

19 A I don't know.

20 Q Do you know how much revenue CHOP received

21 from the sale of RotaTeq?

22 A I do not.

23 Q Did there ever come a time where CHOP sold

24 its interest in the RotaTeq virus vaccine?



Page 64


2 Q Do you remember how much approximately it

3 was sold for?

4 A No.



7 BY MR. SIRI:

8 Q I'm going to hand you what is being marked

9 as Plaintiff's Exhibit 4. This is a press release

10 from Royalty Pharma. And the title of the press

11 release is: Royalty Pharma acquires royalty

12 interest in RotaTeq from the Children's Hospital

13 Foundation for 182 million.

14 MS. RUBY: Ms. Nieusma, you should have

15 that in just one second.

16 BY MR. SIRI:

17 Q Looking at Exhibit No. 4, does that

18 refresh your recollection of how much CHOP sold its

19 interest in RotaTeq for in 2008?

20 A Assuming it's correct, yes.

21 Q Does that sound about right?

22 A I have no idea, but presumably it's

23 correct.

24 Q Do you have any reason to doubt the

25 authenticity of this press release?


Page 65


2 A No.

3 Q Do you have any reason to doubt that CHOP

4 sold its RotaTeq interest in 2008 for $182 million?

5 A I have no reason to doubt it.

6 Q Did you receive a portion of those

7 proceeds?


9 Q What was that amount?

10 A I could not tell you precisely. I really

11 can't. I don't do these things for the money. And

12 although it's gratifying to receive monetary awards,

13 I don't personally keep track of it.

14 Again, if I had realized this was

15 going to be the tone of this deposition, I would

16 have asked my wife to come along.

17 BY MR. SIRI:

18 Q You're here today opining that Faith

19 should receive vaccines that are made by the big

20 four pharmaceutical companies, correct?

21 A I am, yes.

22 Q Okay. And you didn't anticipate that your

23 financial dealings with those companies would be

24 relevant in that issue?

25 A I guess, no, I did not perceive that that


Page 66


2 was relevant to my opinion as to whether a child

3 should receive vaccines. Vaccines have to be made

4 by somebody. And, of course, in this world they're

5 made by pharmaceutical companies who make profits on

6 vaccines.

7 And the fact that they make profits

8 on vaccines has no bearing on whether those vaccines

9 are good for a child or not.

10 Q So you think the fact that pharmaceutical

11 companies make money on vaccines doesn't bias how

12 they approach the promotion of their own products?

13 A I imagine it biases them in favor of

14 vaccines, but so does most of the scientific world.

15 Q Are you saying most of scientific world is

16 biased because of financial --

17 A No.

18 Q -- conflicts of interest?

19 A I'm saying most of the scientific world

20 believes that vaccines protect children against

21 serious diseases.

22 Q Do you have a peer-reviewed study that

23 actually supports what you just said?

24 A Absolutely, yes.

25 Q Okay. Good. We'll make a demand for


Page 67


2 that, too.

3 A Well, you can certainly buy a copy of a

4 Vaccines textbook, which contains thousands of

5 references showing that vaccines work and are safe.

6 Q So from the $182 million sale to CHOP --

7 that CHOP made to Royalty Pharma, do you believe

8 that you received more or less than a million

9 dollars?

10 A I could have received more than a million

11 dollars. I don't have an exact figure.

12 Q You stated earlier your co-inventor on

13 this was Paul Offit?

14 A Yes.

15 Q Were you entitled to similar remuneration

16 as he was?

17 A Yes.

18 Q Are you aware that he has stated publicly

19 how much he's received from that sale?

20 A I am not aware that he has.

21 Q If I told you he said that he received

22 approximately $6 million, would that --

23 A Mm-hmm.

24 Q -- would that help you recall how much you

25 received?


Page 68


2 A Not really, but I believe whatever Paul

3 has said I'm sure is correct.

4 Q So is $6 million a lot of money, in your

5 opinion?

6 A Yes.

7 Q If you received $6 million, do you think

8 you'd remember?

9 A Actually, Counselor, no. I hesitate to

10 say this because it sounds as if I'm some sort of

11 idiot. But I really do not follow what income I

12 get. I have no doubt that it was a lot of money,

13 but I cannot give you an exact figure. I actually

14 do not read my own tax returns. I say that in

15 complete honesty.

16 Q How about the Wistar Institute; I believe

17 you stated earlier they also were held to

18 intellectual property on RotaTeq, correct?

19 A Yes.

20 Q Did there ever come a time -- and you

21 receive a portion of the proceeds that Wistar

22 receives, correct?

23 A Yes.

24 Q And you continue to receive payments from

25 Wistar for the sale of RotaTeq?


Page 69


2 A I don't think I received anything in the

3 last couple of years, but I have in the past.

4 Q How much approximately have you received

5 in the past?

6 A I don't remember.

7 Q Do you recall Wistar selling a portion of

8 its royalty interest to RotaTeq?

9 A I believe they have.

10 Q Do you remember approximately how much?

11 A No.

12 Q I'm going hand you what's been marked as

13 Plaintiff's Exhibit 5.



16 BY MR. SIRI:

17 Q It's a PR Newswire article. Can you read

18 the title, please?

19 A "The Wistar Institute Sells Partial

20 Royalty Interest in Merck's RotaTeq to the Paul

21 Royalty Fund."

22 Q Does that refresh your recollection of how

23 much they sold their royalty interest?

24 A No.

25 MS. RUBY: Ms. Nieusma, did you receive


Page 70


2 Exhibit 5?

3 MS. NIEUSMA: I did. I believe Exhibit 5

4 I have, yep, just got it.

5 MS. RUBY: Thank you.

6 BY MR. SIRI:

7 Q Can you please read the first sentence of

8 the article, Dr. Plotkin.

9 A The Wistar Institute today announced that

10 it sold a portion of its anticipated worldwide

11 royalty revenues from RotaTeq to an affiliate of the

12 Paul Royalty Fund for $45 million.

13 Q Does that refresh your recollection of how

14 much they received for selling a portion of their

15 interest in RotaTeq?

16 A I know that they sold it. I don't have in

17 my head how much they sold it for. But I presume

18 this is correct.

19 Q The Wistar Institute is entitled to what

20 percentage of the sales from the RotaTeq?

21 A I do not know.

22 Q From this $45 million sale, any

23 recollection at all of how much you received?

24 A No recollection. I'm sure I received

25 some.


Page 71


2 Q Do you think it was sizable?

3 A I think it was probably sizable, yes.

4 Q More than a few hundred thousand?

5 A I think so. I don't have a figure in my

6 head.

7 Q Do you have documents that would indicate

8 how much you received?

9 A I would imagine so, yes.

10 MR. SIRI: We'll make a request for those

11 as well.

12 BY MR. SIRI:

13 Q Are you familiar with the Immunization

14 Action Coalition?

15 A Yes.

16 Q What is your understanding of what this

17 group does?

18 A They promote vaccination through education

19 and emails and meetings.

20 Q Would you say it's one of the main

21 advocacy groups for vaccines in this country?

22 A I think it's an important one, yes.

23 Q Does it receive funding from

24 pharmaceutical companies?

25 A I believe -- I think so. I'm not certain.


Page 72


2 I don't know exactly where their financing comes

3 from, but I think they very well may.



6 BY MR. SIRI:

7


9 as Plaintiff's Exhibit 6. It's a printout from the

10 Immunization Action Coalition web page showing their

11 funding for 2017. If you could kindly take a look

12 at that and the section that says, that lists the

13 pharma company donors.

14 A Mm-hmm.

15 Q Are any of the companies listed there

16 vaccine manufacturers trying to develop vaccines?

17 A Yes.

18 Q Which ones?

19 A AstraZeneca, Glaxo, Merck, Pfizer, Sanofi,

20 Seqirus.

21 Q So all of them?

22 A Yes.

23 MS. RUBY: Ms. Nieusma, can you confirm

24 you received Exhibit 6.

25 MS. NIEUSMA: Haven't gotten it yet, but I


Page 73


2 should have it in just a second.

3 Got it.


5 BY MR. SIRI:

6 Q Do you know approximately what percent of

7 Immunization Action Coalition's funding comes from

8 those pharmaceutical companies?

9 A No idea.

10 Q Can you name me a major medical group,

11 such as the American Academy of Pediatrics or

12 similar, that you know does not receive any funding

13 from any pharmaceutical company?

14 A Well, inasmuch I do not know what

15 organizations receive what funding, I really can't

16 answer that question.

17 Q Sitting here today, you don't know of one?

18 A I don't know what funding, for example,

19 AAP receives from manufacturers, no.

20 Q So sitting here today, you're not aware of

21 any medical group that does not receive any support

22 from pharmaceutical companies, correct?

23 A I am not aware of the funding of medical

24 organizations and whether or not they receive

25 funding from pharmaceutical companies.


Page 74


2 Q So just to recap, I think it would be

3 correct to say that you've received in total from

4 the companies that develop or manufacture vaccines

5 payments or remuneration at least in the amount of a

6 few million dollars, correct?

7 A I think it's correct to say that since I

8 left Children's Hospital in the 1990s, I have

9 received considerable funding for my work in

10 developing vaccines and in advising companies how to

11 develop vaccines, and I have also given advice

12 freely to organizations that could not pay me

13 because I believe that vaccines are important to the

14 health of children and adults.

15 Q So the answer is yes?

16 A The answer is yes, but I wish to say very

17 clearly that none of the things that I have done

18 have been done with the objective of gaining money.

19 It has been my fortune that I have

20 been rewarded financially for the work that I've

21 done. But none of the things that I've done have

22 been done for financial gain. And I resent very

23 much the line of questioning that suggests that what

24 I believe and what I've done have been done for

25 financial reasons.


Page 75


2 Q Nobody is suggesting that, Dr. Plotkin.

3 I'm just asking you --

4 A Baloney, you are suggesting that.

5 That's --

6 Q You're suggesting that.

7 Dr. Plotkin, you indicated that a lot

8 of the remuneration you received is from the 1990s.

9 Have you received any funding from the big four

10 pharma companies or their predecessors before 1990?

11 A I would say probably not. You know, it's

12 very hard to remember that far back. But certainly

13 not any substantial funding. I may have received

14 honoraria for attending meetings in those days, but

15 certainly nothing, nothing considerable.

16 At that point I was working at the

17 University of Pennsylvania and the Children's

18 Hospital and the Wistar Institute and was, of

19 course, paid by those entities.

20 MR. SIRI: Could you read the last answer

21 back for me, please.

22 - - -

23 (Whereupon, the Reporter read

24 back a preceding portion of the

25 testimony as directed:


Page 76


2 "A. I would say probably not.

3 You know, it's very hard to

4 remember that far back. But

5 certainly not any substantial

6 funding. I may have received

7 honoraria for attending meetings

8 in those days, but certainly

9 nothing, nothing considerable.

10 At that point I was working at

11 the University of Pennsylvania

12 and the Children's Hospital and

13 the Wistar Institute and was, of

14 course, paid by those

15 entities.")

16 BY MR. SIRI:

17 Q Did you receive any funding from any

18 pharmaceutical company related to the development of

19 vaccines before 1990?

20 A I don't recall receiving any funding for

21 the development of rubella vaccine before it was

22 licensed and then funding passed through Wistar.

23 As far as rotavirus is concerned, I

24 did have grants, not personal money, but grants for

25 rotavirus development from Sanofi. And I had no


Page 77


2 funding for rabies.

3 That's as much as I can recall.

4 Q But you indicated that you didn't get

5 funding for the work on the rubella vaccine, right?

6 A I don't believe I had any funding until it

7 was eventually licensed by Merck.

8 Q When was that?

9 A That was about 1970 -- early '70s.

10 Q So from the early '70s, you were receiving

11 funding, you're saying, from Merck related to

12 rubella?

13 A No. Wistar was receiving funding.

14 Q Wistar from Merck?

15 A Yes.

16 Q Got it. But before that?

17 A Merck did not fund the development of

18 rubella vaccine until it was licensed.

19 MS. RUBY: Ms. Nieusma, you should have

20 Exhibit 7.



23 BY MR. SIRI:

24 Q I'm going hand you, Dr. Plotkin, what's



Page 78


2 MS. NIEUSMA: Just got it.

3 BY MR. SIRI:

4 Q Can you read the title of the article,

5 please.

6 A Attenuation of RA 27/3 Rubella Virus in

7 WI-38 Human Diploid Cells.

8 Q Who is the first listed author?

9 A I am.

10 Q What is the year of this publication?

11 A 1969.

12 Q And if you go to the, if you go to the

13 summary -- you know what? Dr. Plotkin, let me --

14 may I --

15 A Oh, yes.

16 Q Does it say there that Mr. Plotkin is a

17 recipient of an award from Smith, Kline -- is that a

18 predecessor to GSK?

19 A Yes, it is.

20 Q Okay.

21 -- and French, Inc., Philadelphia,

22 for research on rubella vaccine, correct?

23 A Yes. Unfortunately, that was not the

24 vaccine that eventuated; in other words, the RA 27/3

25 was not the really the product of any GSK funding.


Page 79


2 Q Does that refresh your recollection now of

3 maybe what was an earlier time that you received

4 funding from pharmaceutical companies towards

5 development related to a vaccine?

6 A Yes. I --

7 Q Okay.

8 A I did have some funding from GSK, but they

9 had their own candidate rubella vaccine.



12 BY MR. SIRI:

13 Q Dr. Plotkin, I'm going to hand you what

14 has been marked as Plaintiff's Exhibit 8.

15 MS. RUBY: Ms. Nieusma, did you receive

16 that Exhibit 8?

17 MS. NIEUSMA: I'm sure I will.

18 MS. RUBY: It might take a second. It's

19 Dr. Plotkin's Curriculum Vitae.

20 MS. NIEUSMA: I've got a copy of that

21 already.


23 BY MR. SIRI:

24 Q This is your CV, correct, Dr. Plotkin?

25 A Yes.


Page 80


2 Q Did you update this CV recently?

3 A I think it was updated last year, but I'm

4 not sure exactly. It probably doesn't have every

5 last publication.

6 Q On the first page in the top right corner,

7 do you see the date?

8 A June 2017.

9 Q Is that when it was last updated?

10 A Yes.

11 Q If you go to the end, I saw that you went,

12 there are some articles here that were published in

13 2017 in which you're an author?

14 A Yes.

15 Q I think I count one, two, three, four,

16 five, six, seven articles, correct?

17 A I guess.

18 Q Some of these were published within the

19 last few months?

20 A Mm-hmm.

21 Q I think some of them were published in

22 December or November, correct?

23 A Yes.

24 Q So this has been updated very recently,

25 correct?


Page 81


2 A Well, June 2017.

3 Q The articles, if you go to article 794,

4 Rodrigues, Pinto.

5 A Yeah.

6 Q Do you know what month of the year that

7 was published?

8 A No.

9 Q If I told you it was published after June,

10 would that --

11 A Well, I guess my secretary must have added

12 it.

13 Q When is the last time you reviewed this

14 CV?

15 A Probably in June 2017.

16 Q You provided this CV to the attorney for

17 the defendant in this case?

18 A Yes.

19 Q It's quite a hefty CV, Dr. Plotkin. It's

20 over 200 pages. I see there's 794 articles in it

21 which you were the author, correct?

22 A Yes.

23 Q That's a lot of articles. I see a lot of

24 honors, including Who's Who in America since 1978.

25 A Mm-hmm.


Page 82


2 Q You have a number of faculty appointments

3 at a number of universities I see here; one, two,

4 three, four, five, six, seven, eight, nine, ten, 11,

5 12, 13. Any of the faculty appointments missing

6 from this list?

7 A I don't think so.

8 Q I also see that there's, there's, you have

9 a professor emeritus position at University of

10 Pennsylvania and Wistar. Do you teach any courses

11 there?

12 A Yes.

13 Q Do you continue to teach any courses?

14 A Yes.

15 Q What do you teach there?

16 A Participate in the vaccine course at the

17 university and essentially give advice to Wistar.

18 Q And for the university, did you teach a

19 course last semester?

20 A Yes.

21 Q Have you been doing that every year for

22 the last --

23 A Pretty much, yes.

24 Q -- few years?

25 What's the name of the course?


Page 83


2 A Vaccines. I don't remember the exact

3 name. But it's essentially a course in vaccines.

4 Q How many days a week does the class meet?

5 A Oh, two days. Two days a week.

6 Q I see you have a number of hospital and

7 administrative appointments. One, two, three -- you

8 have six of them, right? It looks like they're all

9 at the Children's Hospital of Philadelphia and then

10 Department of Pediatric -- any of your hospital

11 administrative appointments missing from this list,

12 Dr. Plotkin?

13 A No, I don't think so. I do have an

14 appointment at Johns Hopkins, but, yeah.

15 Q What is that?

16 A I'm an adjunct professor.

17 Q Since when?

18 A I think sometime in the 2000s.

19 Q I see you have positions in industry

20 listed, correct?

21 A Yes.

22 Q I see two of them. I see one is from 1991

23 to 1997, the medical and scientific director at the

24 Sanofi --

25 A Yes.


Page 84


2 Q -- right?

3 And 1997-2009, executive advisor to

4 the CO of Sanofi, correct?

5 A Correct.

6 Q But as discussed earlier, since 2009

7 you've also worked for Sanofi, correct?

8 A I have, yes.

9 Q And you worked for Merck?

10 A Yes.

11 Q And Glaxo?

12 A Yes.

13 Q And Pfizer?

14 A Yes.

15 Q How come those aren't listed here,

16 Dr. Plotkin?

17 A Well, they are consultancies. They're not

18 official appointments. I don't have a, let's say, a

19 title at Merck. I'm simply a consultant to them.

20 So it's not in my CV.

21 Q So in providing this CV to your, to

22 defendant's counsel, you didn't think disclosing

23 your affiliations with the very companies whose

24 product you're saying Faith should receive, her

25 pediatrician purchase and provide to her, was


Page 85


2 necessary to disclose?

3 A The CV --

4 Q Strike the question.

5 Let me ask you this: Are you willing

6 to update your CV to disclose all of the connections

7 you have with the big four pharmaceutical companies?

8 A Yes, of course. The CV is --

9 Q Okay.

10 A -- created for, not for the, for legal

11 purposes. This is created to inform people who want

12 to know about my papers and my appointments at

13 various universities.

14 Q You provided this to defendant's counsel,

15 correct?

16 A Yes.

17 Q To show your experience as relevant to

18 being an expert witness in this case, correct?

19 A To show my experience as in the field of

20 vaccines, yes.

21 Q What is Dynavax Technologies?

22 A Dynavax is a company that is working on

23 adjuvantation of vaccines and has recently licensed

24 a hepatitis B vaccine that is more immunogenic than

25 the current vaccines.


Page 86


2 Q This is a for-profit company?

3 A Yes.

4 Q Right. And it's involved in the

5 development of vaccines, right?

6 A Yes.

7 Q You're on the Board of directors of this

8 company, correct?

9 A Correct.

10 Q That affiliation is not disclosed on the

11 CV, correct?

12 A It's not on the CV, no.

13 Q What is VBI Vaccines?

14 A Variation Bio.

15 Q Okay. And what is that?

16 A That's a biotech developing vaccines.

17 Q And this is a for-profit company as well,

18 correct?

19 A Yes.

20 Q And you are also on the Board of Directors

21 of this company, right?

22 A Yes.

23 Q And that affiliation is not disclosed in

24 your CV, correct?

25 A It is not in my CV, no.


Page 87


2 Q What is MyMetics?

3 A MyMetics is a biotech in Europe.

4 Actually, I haven't done anything for them in at

5 least a year now. But I think I'm still officially

6 on their Board.

7 Q You're chairman of their scientific

8 advisory Board, correct?

9 A As I said, I haven't done anything for

10 them for at least a year. So if that is correct,

11 that's sort of an old thing.

12 Q But they're a for-profit company?

13 A Yes.

14 Q And how long were you on their Board?

15 A Couple of years. I don't remember

16 exactly.

17 Q But that affiliation is not on your CV,

18 correct?

19 A No.

20 Q Dynavax Technologies, what have you done

21 for them?

22 A Dynavax, I've been on their Board.

23 Q You attend the Board meetings?

24 A Not recently, but, yes, in the past.

25 Q Have you advocated on their behalf?


Page 88


2 A Yes.

3 Q Have you done that in any government

4 meetings, for example?

5 A Yes. Yes.

6 Q To seek licensure of the vaccine?

7 A Yes. It was just licensed.

8 Q And so you were advocating as a Board

9 member of a technology company to get licensure of a

10 new vaccine, correct?

11 A Yes.

12 VIDEO OPERATOR: We have five minutes left

13 on the disc.

14 MR. SIRI: Okay.

15 BY MR. SIRI:

16 Q Inovio Biomedical Corp., what's that?

17 A That's a biotech that's developing

18 vaccines based on DNA.

19 Q And is this a for-profit company?

20 A Yes.

21 Q And what is your affiliation with the

22 company?

23 A I'm on their Board.

24 Q And was that affiliation disclosed in your

25 CV?


Page 89


2 A No.

3 Q What's CureVac AG?

4 A It's also a biotech.

5 Q Is it a for-profit company?

6 A Yes.

7 Q Is it involved in the development of

8 vaccines?

9 A Yes.

10 Q What's your affiliation with that company?

11 A I'm on their Board.

12 Q Did you, is that affiliation disclosed in

13 your CV?

14 A No.

15 Q What is Syn, S-Y-N, Vaccine?

16 A Actually, I'm not sure about that, about

17 that name. But as I recall, it's a company trying

18 to develop synthetic vaccines.


20 A Actually, I don't recall that -- I've

21 certainly helped them, but I don't recall that I

22 have a Board position or whether I'm officially on

23 the Board or not. I haven't had contact with them

24 for some time.

25 Q What is GeoVax Labs?


Page 90


2 A It's also a biotech.


4 A Yes.

5 Q Is it involved in the development of

6 vaccines?

7 A Yes.


9 A I've been an advisor, and I think I'm

10 officially on their Board. They're trying to

11 develop a vaccine against HIV.

12 Q Was this association disclosed in your

13 CV -- no, right?

14 A No. I don't have my consultancies on my

15 CV.

16 Q You're on the Board of these companies,

17 correct?

18 A Yes.

19 Q What is GlycoVaxyn AG? That's G-L-Y-C-O,

20 then capital V, A-X-Y-N AG?

21 A It was a biotech in Europe.


23 A It was.

24 Q Okay. Was it involved in the development

25 of vaccines?


Page 91


2 A Yes.

3 Q Were you on the Board of this company as

4 well?

5 A Yes.

6 Q Did you, is that disclosed in your CV?

7 A No.

8 Q What is Adjuvance Technologies? That's

9 A-D-J-U-V-A-N-C-E, Technologies?

10 A It's a company trying to developed

11 adjuvants for vaccines.


13 A Yes.

14 Q You're on the Board of this company as

15 well, right?

16 A Yes.

17 Q And that affiliation isn't disclosed in

18 your CV either, right?

19 A No.

20 Q What is BioNet-Asia?

21 A A company developing a new pertussis

22 vaccine.

23 Q This is a for-profit company as well?

24 A Yes.

25 Q And you're on the Board of this company as


Page 92


2 well?

3 A Yes.

4 Q That affiliation also wasn't disclosed in

5 your CV, correct?

6 A Correct.

7 Q What's Abcombi -- that's A-B-C-O-M-B-I --

8 Biosciences?

9 A I haven't heard from them in a long time.

10 Actually, I'm not even sure -- I mean, I had an

11 interview with the founder once. Whether he listed

12 me as a Board member, I don't know. I haven't heard

13 from him in a long time.

14 Q It's a for-profit company?

15 A I really have no idea. I assume it is,

16 but I don't know.

17 Q I should say that I'm spelling them out

18 for the benefit of the court reporter. I assume you

19 know the spelling. I'm just doing it for the

20 benefit of the court reporter.

21 What's Hookipa Biotech? That's --

22 A Oh, Hookipa?

23 Q Thank you.

24 A Yeah.

25 Q H-O-O-K-I-P-I-A [sic] Biotech.


Page 93


2 A Yes. It's a European biotech.


4 A Yes.

5 Q And it's involved in the development of

6 vaccines?

7 A Yes, hopefully.

8 Q And you're also on the Board of this

9 company?

10 A Yes.

11 Q And that affiliation also wasn't disclosed

12 in your CV, right?

13 A No.

14 Q You mentioned one of the companies was in

15 the process of developing a new, trying to develop a

16 new pertussis vaccine. Which company was that?

17 A BioNet.

18 Q Thank you.

19 Why are they trying to develop a new

20 pertussis vaccine?

21 A Because the problem with current acellular

22 vaccines is that, although they are protective, the

23 protection doesn't last as long as we would like.

24 And BioNet has developed a component of pertussis

25 vaccine that should give longer-lasting responses.


Page 94


2 Q How long does the current immunity last

3 from the current acellular pertussis vaccine?

4 A Well, it lasts for probably on the order

5 of five years, but the efficacy diminishes after two

6 years or so. And the result is that there have been

7 more pertussis in adolescents than we would like.

8 Q So when you say after five years immunity

9 is gone in two years, the efficacy, do you mean

10 after -- how many dose -- the four- or five-dose

11 DTaP series?

12 A Well, I should go into some detail. The

13 first --

14 VIDEO OPERATOR: Thirty seconds.

15 BY MR. SIRI:

16 Q Well --

17 A The first three doses are given --

18 Q You know what? I apologize. The, it's

19 about the run out, and I don't want to give the

20 videographer a hard time.

21 VIDEO OPERATOR: This ends disc one of the

22 deposition of Dr. Stanley Plotkin. We're going

23 off the record. The time is 10:32.

24 (Brief recess.)

25 VIDEO OPERATOR: This is the beginning of


Page 95


2 tape No. 2 of the deposition of Dr. Stanley

3 Plotkin. We are on the record. The time is

4 10:42.

5 MR. SIRI: Thank you.

6 BY MR. SIRI:

7 Q Apologies, again, for cutting off the

8 answer to your last question. The tape needed to be

9 changed.

10 MR. SIRI: If you could kindly read back

11 the last question to give Dr. Plotkin an

12 opportunity to respond.

13 - - -




17 "Q. So when you say after five

18 years immunity is gone in two

19 years, the efficacy, do you mean

20 after -- the four- or five-dose

21 DTaP series?

22 "A I should go into some

23 detail. The first --

24 "Q Well --

25 "A The first three doses are


Page 96


2 given --

3 "Q You know what? I apologize.

4 It's about the run out.")

5 THE WITNESS: So pertussis vaccine is

6 given in three doses in infancy and is quite

7 protective during the childhood or infancy

8 years.

9 Then there's a booster dose given before

10 school entry, and that results in protection,

11 pretty good protection for two, three years,

12 but then begins to fade when the child reaches

13 eight or nine years.

14 And a dose is recommended in

15 preadolescents. And there in particular what's

16 been found is that with the so-called acellular

17 vaccines, that after two or three years, that

18 the efficacy diminishes considerably. And so

19 there are efforts to try to improve that

20 persistence of efficacy.

21 And BioNet is one of the companies that

22 is, in effect, trying to develop a

23 longer-lasting acellular pertussis vaccine.

24 There are other companies also working to

25 improve the vaccine for adolescents.


Page 97


2 BY MR. SIRI:

3 Q So the last vaccine recommended for

4 adolescents is around what age, of DTaP or

5 diphtheria-, tetanus-, and pertussis-containing

6 vaccine?

7 A Thirteen, 11.

8 Q Eleven, 13.

9 A Thirteen.

10 Q And did I understand correctly that a few

11 years after that last dose, the most folks who have

12 gotten that vaccine are no longer immune to

13 pertussis?

14 A Well, "most folks" is perhaps a bit of an

15 exaggeration --

16 Q Okay.

17 A -- but it depends on the study. But

18 certainly I would say that the high effectiveness

19 that's seen initially after the vaccine diminishes

20 considerably by five years.

21 Q What do you mean by "considerably"?

22 A Well, so it falls somewhere between 30 to

23 50 percent protection, so it's not nearly as good as

24 after the vaccine dose is given.

25 Q So after the last vaccine dose in


Page 98


2 adolescents, five years later only 30 to 50 percent

3 of people are -- receiving these CDC-recommended

4 childhood schedule are protected from pertussis?

5 A Yes.

6 Q How about ten years out?

7 A I'm not sure there are many studies that

8 go that far out. But I would imagine that the

9 protection is diminished considerably by that time.

10 Q So most adults aren't protected for

11 pertussis?

12 A Not unless they've received a booster

13 dose. But that being said, it becomes complicated

14 because if they are infected with the organism that

15 causes pertussis, even if they are not ill because

16 of it, they will get a natural booster, and so they

17 may not have symptomatic pertussis.

18 Pertussis is not uncommon in adults.

19 But the epidemiology is not as well established as

20 it is for children.

21 Q But in terms of protection from

22 vaccination from pertussis, most adults are not

23 protected from the vaccination; you're saying

24 they're, if they're protected, they're protected

25 from exposure to the actual pertussis --


Page 99


2 A Yeah.

3 Q -- is it bacteria?

4 A Yes. But, you know, you have to bear in

5 mind that pertussis as a disease is most important

6 in the newborn and in children. And fortunately, we

7 have very effective means of preventing pertussis in

8 those highly susceptible individuals.

9 Adults will have a cough disease, but

10 they won't die of pertussis. So although we want to

11 protect them as well, the main point of pertussis

12 vaccine is to protect the newborn and the young

13 child.

14 Q So is it only really dangerous in the

15 first, what, few months of life? Or --

16 A Yes. Infants with pertussis may

17 frequently die of pertussis. And that's why

18 immunization in pregnancy is now practiced. In

19 other words, to provide passive immunity to the

20 infant during the first months of life before the

21 infant is vaccinated.

22 Q And if the mother had been exposed to

23 pertussis bacteria itself and had immunity that way,

24 that would also confer immunity to the baby?

25 A Yes. But one can't depend on that;


Page 100


2 whereas, if you give a dose of vaccine during

3 pregnancy, you can depend on the antibodies passing

4 to the infant.

5 Q Does the cellular pertussis vaccine

6 prevent the infection and transmission of pertussis

7 in the person vaccinated with acellular pertussis

8 vaccine?

9 A Well, that's an area of active research.

10 It appears that the acellular vaccines don't protect

11 the individual from carrying the organism as much as

12 the so-called whole-cell pertussis vaccines did.

13 But those data are based largely on animal studies,

14 and we don't really have a lot of human data to tell

15 us whether the animal results are true in humans or

16 not.

17 But there is a concern that the

18 acellular vaccines may not protect an individual

19 from passing the organism to another individual even

20 if the vaccinated person doesn't get sick himself or

21 herself.

22 Q What animals are used in those studies?

23 A Baboons.

24 Q Why were baboons used?

25 A Why were baboons used? Because they are


Page 101


2 susceptible to pertussis, and obviously they are

3 close to humans.

4 Q Would those experiments be ethical to do

5 with people as opposed to baboons?

6 A Well, I'm not sure it would be ethical to

7 infect someone with pertussis. That would require

8 an ethical committee to consider what, how the

9 experiment would be done.

10 For example, if someone were infected

11 with pertussis and then given antibiotics soon after

12 administration of the organism, that could be

13 ethical because the antibiotics would cure the

14 individual before he or she becomes ill.

15 Q Wouldn't that mess up the study, though?

16 A Sorry?

17 Q Wouldn't that, but then wouldn't that mess

18 up the study in terms of --

19 A It would certainly influence the study.

20 But it could allow us to determine whether an

21 individual who has been vaccinated with the

22 acellular vaccine can pass the organism, despite the

23 vaccination, to another individual.

24 Q Has that study been done?

25 A No, that has not yet been done.


Page 102


2 Q In terms of the study that was done with

3 baboons, that study --

4 A Yes.

5 Q -- could that study be done with human --

6 do you think any IRB approval could ever be obtained

7 to do that study with humans?

8 A To allow an individual to develop

9 symptomatic pertussis? I don't think that would be

10 approved.

11 Q Okay. What was, so in terms of the baboon

12 studies that were done, that's about as, those are

13 about as good as you're going to get for those

14 studies because you can't do the human studies,

15 correct?

16 A Well --

17 Q In terms of evidence about the

18 transmissibility and infection of pertussis from --

19 A Yes, but --

20 Q -- after acellular pertussis vaccination.

21 A Yes. But I, I believe that workers are

22 trying to determine whether vaccinated individuals

23 are still colonized by the pertussis organism.

24 If they are colonized, then they

25 probably could transmit to others. I mean, there's


Page 103


2 a lot of work going on in this field, including

3 developing an attenuated Bordetella pertussis which

4 could be given to boost immunity and, in particular,

5 to prevent carriage. So as I said, this is a very

6 active area of investigation.

7 Q What was Merck's total revenue from

8 vaccine sales in 2016?

9 A No idea.

10 Q Do you think it was in the millions?

11 A I imagine so. But I certainly have no

12 knowledge.

13 Q Do you think it was in the billions?

14 A I don't, do not know.

15 Q Do you know what the, do you know what the

16 global sales of vaccines were, approximately, last

17 year?

18 A My vague recollection is something like

19 30 billion.

20 Q Thirty billion. Do you know what percent

21 approximately Merck's share of that was?

22 A No.

23 Q Sanofi's?

24 A No.

25 Q Glaxo?


Page 104


2 A No.

3 Q Or Pfizer?

4 A No.

5 Q Do you -- combined what, do you have a

6 sense of what those four represent in terms of that

7 $30 billion in vaccine sales?

8 A Probably. I would guess, but it's purely

9 a guess, 20 billion.

10 Q And the increase in the vaccine market has

11 been due to the fact that new vaccines give higher

12 profits, correct?

13 A Correct.

14 Q Are you familiar with the New England --

15 strike that.

16 If I told you -- in terms of the

17 $30 billion, and you said approximately -- what

18 percent did you say approximately you thought was

19 from the big four vaccine makers?

20 A I said 20. I really don't have an

21 accurate idea, but that's my guess.

22 Q Twenty?

23 A Billion.

24 Q Oh, billion. You said what percent of

25 that was related from the four, to the four big


Page 105


2 vaccine manufacturers?

3 A What I said was that I thought the overall

4 income was 30, but that the big four probably

5 account for 20. But that's, those are purely

6 guesses.

7 Q Then let's do this. When you say it's a

8 guess, how off do you think you might be?

9 A If it's a guess, how do I know how off I

10 am?

11 Q How did you come up with the 20 billion?

12 A Because I vaguely recall having seen a

13 paper with those numbers. But my memory may be

14 incorrect.

15 Q Are you familiar with the New England

16 Journal of Medicine?


18 Q What does an editor for this journal do,

19 does?

20 A What does an editor for the journal do?

21 Q Yeah.

22 A I presume that he edits articles that are

23 submitted to the journal.

24 Q What does the editor in chief do?

25 A Selects articles to be published.


Page 106


2 Q What is your opinion about this, the

3 New England Journal of medicine?

4 A It is an influential medical journal.

5 Q I'm going to read you a quote from a

6 Dr. Edmond J. Safra, professor at Harvard Medical

7 School and former editor in chief at the New England

8 Journal of Medicine.

9 And I'm going to ask you a question

10 about it. Okay?

11 A Yes.

12 Q So the quote says: Conflicts of interest

13 and biases exist in virtually every field of

14 medicine, particularly those that rely heavily on

15 drugs or devices. It is no longer possible to

16 believe much of the clinical research that is

17 published or to rely on the judgment of trusted

18 physicians or authoritative medical guidelines. I

19 take no pleasure in this conclusion, which I reached

20 slowly and reluctantly over my two decades as the

21 editor of the New England Journal of Medicine.

22 Are you familiar with that quote?

23 A No.

24 Q Okay. Let me read you a different quote,

25 again, by Dr. Angell, in which she blames the issue


Page 107


2 that I just quoted, the issues with truths in

3 medical publishing, on individuals that use

4 legitimacy of academia to push pharmaceutical

5 company agendas. Here's what she said about those

6 individuals.

7 She says, quote: They serve as

8 consultants to the same companies whose products

9 they evaluate, join corporate advisory boards and

10 speakers bureaus, enter into patent and royalty

11 arrangements, agree to be the listed authors of

12 articles ghostwritten by interested companies,

13 promote drugs and devices at company-sponsored

14 symposia, and allow themselves be plied with

15 expensive gifts and trips to luxurious settings.

16 Many also have equity interest in sponsoring

17 companies.

18 Are you familiar with that quote?

19 A Yes. I think I have read that, mm-hmm.

20 Q You consulted for the big four vaccine

21 manufacturers, correct?

22 A Yes.

23 Q You're in the corporate advisory Board of

24 numerous vaccine developers, correct?

25 A Yes.


Page 108


2 Q You've received royalties from the sale of

3 one or more vaccines, correct?

4 A Yes.

5 Q Have you received -- you have received

6 royalties from the sale of one or more vaccines,

7 correct?

8 A Yes.

9 Q You are listed as an author on at least

10 one or more papers where individuals authoring

11 papers receive compensation from vaccine makers,

12 correct?

13 A Would you repeat that question.

14 Q Sure. Have any of your co-authors on any

15 of the papers that you've published received

16 compensation from pharmaceutical companies?

17 A Presumably, yes.

18 Q And you've taken numerous trips over the

19 last 30 years to various parts of the world?

20 A Yes.

21 Q I'm going read you a list of acronyms.

22 And for the record, could you please state what you

23 understand each to be. This way we can have

24 commonality in terms of language.

25 HHS?


Page 109


2 A Health and Human Services.

3 Q Okay. CDC.

4 I know these, I know that you know

5 these. This is just so that when I use the term

6 "CDC" later we have it defined.

7 A Centers for Disease Control.

8 Q Thank you. Thank you.

9 Have you ever been involved with the

10 CDC?


12 Q What's been your involvement?

13 A Well, actually, I was an epidemic

14 intelligence service officer in the 1950s, and I

15 have served on committees. I've attended numerous

16 meetings at CDC. I've worked or, let's say,

17 collaborated frequently with people from CDC. CDC

18 is the world's most important epidemiology

19 organization.

20 Q FDA?

21 A Yes. I've actually done consultation for

22 FDA and interacted with people on FDA, yes.

23 Q And it stands for the Food and Drug

24 Administration?

25 A Food and Drug Administration, yes.


Page 110


2 Q And the FDA is an agency within HHS,

3 correct?

4 A Yes.

5 Q And CDC's also an agency within HHS?

6 A Yes.

7 Q Okay. NIH?

8 A Yes, of course. National Institutes of

9 Health.

10 Q Right. And you've been involved with the

11 NIH?

12 A Yes.

13 Q And how have you been involved?

14 A Served on committees, worked with people

15 at NIH, scientific collaborations.

16 Q NIH is an agency within HHS as well,

17 correct?

18 A Yes.

19 Q HRSA?

20 A I'm not sure --

21 Q Health Resources Services Administration?

22 A Okay.

23 Q They're also an agency within HHS,

24 correct?

25 A Yes.


Page 111


2 Q Any involvement with HRSA?


4 Q ACIP?

5 A Well, yes. The Advisory Committee for

6 Immunization Practices. I have attended their

7 meetings since 1960s, probably.

8 Q Have you ever served on the Board at ACIP?

9 A On ACIP itself? No.

10 Q Okay.

11 A No.

12 Q Have you served on any Board related to

13 ACIP?

14 A To ACIP? I've worked, I have participated

15 in working groups which they have organized on

16 specific subjects.

17 Q What working groups were those?

18 A Let's see. Mumps. Let's see. What else?

19 Mumps was the most recent one. I can't recall for

20 the moment. But anyway, two or three working groups

21 that they've organized from time to time. A yellow

22 fever was one.

23 Q Ever work on a working group for

24 rotavirus?

25 A Actually, no.


Page 112


2 Q And measles?

3 A Measles? No.

4 Q Not measles. I'm sorry.

5 Rubella?

6 A No, not for ACIP, no.

7 Q A different government agency?

8 A No. Actually, that was for WHO.

9 Q For the rubella?

10 A Yes.

11 Q And for rotavirus, did you serve on a

12 committee --

13 A No.

14 Q -- for any other governmental entity?

15 Strike that. That's okay.

16 Oh, and WHO stands for?

17 A World Health Organization.

18 Q Thank you.

19 I don't know if I'm going to

20 pronounce this acronym correct. You can correct me

21 if I don't. Is it VRBPAC? VRBPAC? VRBPAC? How is

22 it normally pronounced?

23 A "VRBPAC." Vaccines and Related

24 Biologicals Advisory Committee.

25 Q And that's V-R-B-P-A-C?


Page 113


2 A Yeah.

3 Q Any involvement with that committee?

4 A I have testified, but not, I have not

5 served on the committee.

6 Q What did you testify there for?

7 A On the, at least the last time concerned

8 the Dynavax vaccine.

9 Q Oh, the, for the company you're on the

10 Board for?

11 A Yes.

12 Q And this was to try to seek approval of

13 that vaccine?

14 A Yes.

15 Q Which ended up getting approved?

16 A Yes.

17 Q The NVAC?

18 A National Vaccine Advisory Committee. I've

19 given talks to the committee.

20 Q Okay. About what?

21 A About vaccines.

22 Q Fair enough. Anything in particular about

23 vaccines or particular vaccines?

24 A No. Actually, there was more or less

25 general. It was not pushing any particular vaccine,


Page 114


2 but relation to the administration and the

3 development of new vaccines.

4 Q Ever give a presentation about the vaccine

5 market?

6 A About the vaccine market? No.

7 Q And so all of the agencies and committees

8 we just listed, CDC, FDA, NIH, HRSA, ACIP, VRBPAC,

9 and NVAC, they're all under HHS?


11 Q And what's the, what about IOM; what does

12 that stand for?

13 A Institute of Medicine, now the National

14 Academy of Medicine.

15 Q Have you ever been involved with IOM?

16 A Well, I'm a member of the National

17 Academy. So yes.

18 Q Since when have you been a member?

19 A Oh, gosh. Ten years, but that's just a

20 guess.

21 Q What is the National Childhood Vaccine

22 Injury Act of 1986?

23 A Well, that's, in effect, it funds the

24 organization that, shall I say, receives requests

25 from individuals who believe that they've been


Page 115


2 injured by vaccines and remunerates them if they

3 decide that, that there was a possibility that the

4 vaccine did cause injury.

5 Q So if somebody is injured by a vaccine,

6 this law provides that they submit a claim to Health

7 and Human Services?

8 A Yes.

9 Q And Health and Human Services then

10 adjudicates --

11 A Yes.

12 Q -- and those claims are filed in something

13 called the Vaccine Injury Compensation Program,

14 correct?

15 A Yes.

16 Q Administered in DC?

17 A Yes.

18 Q So, and the respondent in those cases is

19 HHS, the secretary of HHS?

20 A Yes.

21 Q And the secretary of HHS in those cases is

22 represented by the Department of Justice?

23 A Yes.

24 Q To defend against claims that the vaccines

25 cause injury, right?


Page 116


2 A I would say that they determine whether

3 there is a reasonable possibility that the vaccine

4 caused injury. They, I would say, are relatively

5 open and will give an award if there is a reasonable

6 possibility.

7 When this was first organized --

8 Q Do you have a study that supports what you

9 just said or any type of --

10 A About what?

11 Q That they are very, that they are open to

12 giving awards? Do you have any governmental report

13 or any authoritative source, any kind of

14 governmental report or similar that supports the

15 assertion you just made?

16 A Well, I don't know. I'd have to look that

17 up.

18 Q Okay.

19 A But the principle was enunciated years ago

20 by the, particularly by the American Academy of

21 Pediatrics. And their idea, which I now think was a

22 good idea, was that rather than have an adversary

23 situation, that they would set up an organization

24 whereby if there was a reasonable possibility of

25 injury, that they would offer remuneration, as


Page 117


2 opposed to the situation where lawsuits were being

3 filed against companies and having an impact on

4 whether the company was continuing -- would continue

5 to make the vaccine.

6 At a certain point there were

7 relatively few companies making vaccines. And so

8 this is an idea which over the years I have realized

9 was a good idea, because it removed the -- how shall

10 I say? -- the oppositional part of the story and

11 made it possible for people who thought that they

12 had been injured to be remunerated, whether or not

13 that was biologically the case.

14 Q So is it your testimony that the national,

15 that the Vaccine Injury Compensation Program is not

16 an adversarial system?

17 A It's an adversarial system in that people

18 have to have some reasonable information base to say

19 that a child, let's say, has been injured. Whether

20 it's because of a vaccine or whether it's a chance

21 occurrence fortunately does not have to be

22 adjudicated under this kind of system.

23 Q That's only if it's a table injury,

24 correct?

25 A Yes.


Page 118


2 Q But if it's not a table injury, then the

3 petitioner would need --

4 A Yes.

5 Q -- to show that it was the vaccine that

6 caused the injury?

7 A Yes.

8 Q So this is, I'm going to refer to this as

9 the 1986 act. This is the act that gave vaccine

10 manufacturers immunity from liability.

11 A Yes.

12 Q And you have to -- yeah, okay, for

13 injuries caused by vaccines.

14 A Mm-hmm. Yes.

15 Q What is a bacteria?

16 A It's a microorganism which has certain

17 properties. It has a cell wall. And it has DNA

18 within, within the organism. And it can, depending

19 on what bacteria it is, it can multiply in humans

20 and sometimes cause disease.

21 Q How does it replicate?

22 A It divides. It has mechanisms for

23 dividing and multiplying.

24 Q What is a virus?

25 A A virus is a DNA or RNA molecule with


Page 119


2 properties to produce proteins and to replicate in

3 cells and make more of it and is capable of causing

4 disease under certain circumstances.

5 Q When you say "replicate in cells" --

6 A Yes.

7 Q -- do you mean in the host, the person

8 that it infects?

9 A Yes.

10 Q So it takes over the person it infects own

11 cellular DNA material?

12 A Well, it doesn't take over the DNA

13 necessarily, but it is able to replicate in cells

14 that which, of course, have DNA. Not all viruses

15 require that that they influence the DNA of the

16 cell. But they all are able to replicate in the

17 cytoplasm or in the nucleus of the cells of the

18 host.

19 Q And in that fashion, they will spread from

20 cell to cell?

21 A Yes.

22 Q By duplicating themselves into more and

23 more cells in the body?

24 A Yes.

25 Q And the virus DNA will, you said it can be


Page 120


2 either DNA or RNA?

3 A Yes.

4 Q And those DNA and RNA pieces, they provide

5 coating for protein structures?

6 A Yes.

7 Q Those protein structures are typically,

8 DNA creates protein structures that are important

9 for regulating bodily functions?

10 A Well, the virus is --

11 Q I mean DNA in general. I'm sorry.

12 A Oh, DNA in general, yes. DNA in general

13 codes for RNA, which then codes for proteins.

14 Q Essential for human life?

15 A Yes.

16 Q And is DNA shared across humans, meaning

17 is there similarity between the DNA sequence in

18 different people?

19 A There are similarities, yes, and there are

20 differences.

21 Q What percent of, you know, is the,

22 similarity is there between human DNA amongst

23 individuals?

24 A Well, there are mostly similarities; but

25 there are, of course, differences. That's why we


Page 121


2 are each different from one another.

3 Q I've read -- tell me if this is not

4 accurate -- that human DNA is approximately among

5 individuals 99.9 similar among different people --

6 A Yeah.

7 Q -- is that correct?

8 A Yes.

9 Q Okay.

10 A But that still allows for differences.

11 Q Right. Some of us have different eye

12 color.

13 A Mm-hmm.

14 Q Yes?

15 A Sorry. Yes.

16 Q Do all humans and mammals -- strike that.

17 What is the percentage of similarity

18 between human DNA and the DNA in mammals of

19 different kinds? Why don't we start with, why don't

20 we start with -- sorry.

21 Why don't we start with primates.

22 A Well, the similarities are in the upper

23 90s, no doubt. But one has to appreciate that the

24 differences that occur are critical and result in

25 critical differences. So the fact that we're, let's


Page 122


2 say, 99 percent similar to chimpanzee doesn't mean

3 that the differences are, the 1 percent difference

4 is unimportant, because much of the DNA actually,

5 the function of most of the DNA is unknown.

6 Q So humans have approximately, between

7 humans, have about 99.99 percent similarity in DNA

8 and between humans and, I think you said,

9 chimpanzees, about 99 percent similarity --

10 A Yeah.

11 Q -- in terms of sequence?

12 A Yes.

13 Q What about for other mammals such as,

14 let's say, between humans and chickens or cows or --

15 is there a similarity?

16 A Well, there's similarity, certainly, but

17 there are key differences. That's what I was

18 referring to. Even though much of the DNA is the

19 same, most of the DNA that we have, the function of

20 which is unknown.

21 Q And what percent would you say is similar?

22 A With chickens, I don't know offhand.

23 Q Cows?

24 A Again, I don't know the number. But the

25 point is that it doesn't require a large percentage


Page 123


2 of the DNA to be different.

3 Q Sure. What about guinea pigs?

4 A (Indicating.)

5 Q If you don't know, that's fine. You can

6 just say you don't know.

7 A I don't know.

8 Q Okay. Are you familiar with how the CDC

9 makes changes to its pediatric vaccine schedule?

10 A Yes.

11 Q Have you ever been part of that process?

12 A Not part of the process, but certainly

13 part of the discussion.

14 Q In addition to changes to the CDC

15 pediatric schedule voted upon by ACIP, correct?

16 A Yes.

17 Q What happens when ACIP votes for a

18 pediatric vaccine to be added to the CDC's pediatric

19 vaccine schedule for universal use?

20 A It is adopted by various medical

21 organizations and recommended to the physicians.

22 Q And so the pediatricians around the

23 country rely on those recommendations to decide

24 whether or not to administer a vaccine?

25 A Absolutely.


Page 124


2 Q What about children in the United States

3 that can't afford the vaccines recommended by ACIP?

4 A Well, until the present time, remains to

5 be seen whether that will still be the case, the

6 government pays for those children to receive

7 vaccines.

8 Q Is that called the Vaccines for Children

9 Program?

10 A Yes.

11 Q And ACIP votes on whether or not to add a

12 vaccine to that program, correct?

13 A Yes.

14 Q And when a vaccine is added to that

15 program, the manufacturer is paid for the vaccine

16 even if the child can't pay, correct?

17 A Correct.

18 Q Do you know what percentage of vaccines,

19 pediatric vaccines administered in the United States

20 are purchased from pharmaceutical companies using

21 federal money through the Vaccines for Children

22 Program?

23 A Fifty to 60 percent.

24 Q So when ACIP recommends a vaccine for

25 universal use, it will essentially create a


Page 125


2 liability-free market of millions of children for

3 the pharmaceutical company manufacturing that

4 vaccine, right?

5 A The act provides payment to the

6 pharmaceutical company to manufacture the vaccine;

7 that is correct.

8 Q Are you talking about the 1986 act?

9 A Yes.

10 Q And they're not liable for injuries from

11 the vaccines, right?

12 A Unless it is the result of bad

13 manufacture.

14 Q But not for, if it wasn't, not for design

15 defect claims?

16 A Right.

17 Q Meaning you can't sue a vaccine

18 manufacturer claiming that they could have made the

19 vaccine safer?

20 A Correct.

21 Q Who comprises the voting members of ACIP?

22 Strike that. I didn't want the names.

23 Let me ask it a different way. Are

24 the individuals that serve on ACIP government

25 employees?


Page 126


2 A No.

3 Q Where do these individuals come from?

4 A They come from all over the United States,

5 and they are chosen because they have no conflict of

6 interest; that is to say, they receive no funding

7 from vaccine companies but are thought to know

8 something about vaccines, nevertheless, with the

9 exception of a community representative who is a

10 layperson.

11 Q So none of the members of ACIP have any

12 conflict with regards to the manufacture,

13 development, or -- of vaccination?

14 A Right.

15 Q When was the first rotavirus approved by

16 ACIP for universal pediatric use?

17 A That was, I don't remember the year, but

18 my recollection is that was in the 1990s.

19 Q If I tell you June 25, 1998, does that jog

20 your memory?

21 A Yeah, that could be right.

22 Q On that date, June 25, 1998, you and your

23 co-inventors, Paul Offit and Fred Clark, had already

24 had a patent on the rotavirus vaccine, correct?

25 A Yes.


Page 127


2 Q Were you at ACIP at the meeting that they

3 first approved the first-ever rotavirus vaccine for

4 universal pediatric use?

5 A I believe I was.

6 Q Was Fred Clark at that meeting?

7 A I think he was. I'm not certain.

8 Q Was Paul Offit at that meeting?

9 A Yes.

10 Q What was Paul Offit's role at that

11 meeting?

12 A His role? I don't remember whether he was

13 still on the committee or not. I don't remember.

14 Q He was on ACIP?

15 A He was on ACIP, yes.

16 Q He was a voting member of ACIP?

17 A But I am confident that he was not allowed

18 to vote on the licensure of RotaTeq or on the

19 administration of RotaTeq.

20 Q For the first, what was the first

21 rotavirus vaccine that was approved for universal

22 use in this country?

23 A RotaTeq.

24 Q Is that the rotavirus vaccine that you

25 worked on?


Page 128


2 A Yes.

3 Q There wasn't a rotavirus vaccine that was

4 approved before that?

5 A I don't believe so, no -- well, yes, there

6 was a vaccine that had been developed at the

7 National Institutes of Health that had been

8 licensed, but was found to cause intussusception,

9 and the manufacturer took it off the market.

10 Q Paul Offit was on the committee and voted

11 to approve that vaccine for universal use, correct?

12 A Very likely, yes.

13 Q At the time that he voted to approve that

14 rotavirus vaccine for universal use, he was a patent

15 holder with you and Fred Clark on a rotavirus

16 vaccine, correct?

17 A Yes.

18 Q He didn't recuse himself from voting on

19 recommending the rotavirus vaccine for universal use

20 at that meeting, correct?

21 A That's correct, which in a sense was

22 voting against himself since obviously he was in

23 favor of the vaccine that we were trying to develop.

24 So in effect, he was voting for a competitor.

25 Q When you have one vaccine for a given


Page 129


2 disease approved for universal use, wouldn't that

3 make it easier to, then, have another vaccine for

4 that same disease approved for universal use?

5 A Assuming that the properties of the second

6 vaccine were equal to or better than the first, yes.

7 Q So approval of the first one paves the way

8 for the second one, doesn't it?

9 A It paves the way in the sense that if

10 people believe that rotavirus disease is worth

11 preventing, they will want more than one vaccine

12 licensed so that in case there's a shortage of

13 supply in one vaccine, there's an alternative.

14 Q So there's, so there's, once you have one

15 approved, it's a good idea to have a second one

16 approved, then, isn't it?

17 A It is, yes.

18 Q Yeah. Are you aware of the many other

19 conflicts of interest regarding the vote to approve

20 the rotavirus vaccine for universal use that we've

21 just been discussing that's been reported in a U.S.

22 House of Representatives Committee on Government

23 Reform report?

24 A No.

25 Q Are you aware that this report found that,


Page 130


2 quote, the overwhelming majority of members, both

3 voting members and consultants, have substantial

4 ties to the pharmaceutical industry, end quote?

5 Well, I can't go back to 1998. But

6 at the moment, my criticism of the ACIP committee is

7 that many of the people on the committee do not have

8 a very large knowledge about vaccines because they

9 are eliminated from participating on the committee

10 if they have any connections with, with industry.

11 And I understand why that is the

12 case, but it does result in the group of people who

13 aren't necessarily the best informed.

14 That being said, I agree with the

15 idea that people who are on the ACIP should have no

16 conflict of interest.

17 VIDEO OPERATOR: Watch your notes up

18 against your microphone.

19 MS. NIEUSMA: Pardon?

20 MR. SIRI: The videographer was kindly

21 advising me not to keep smacking my mic that's

22 pinned to my tie.

23 MS. NIEUSMA: Got you.

24 BY MR. SIRI:

25 Q Last question on this. Are you aware that


Page 131


2 the report, that this report by the U.S. House of

3 Representatives' Committee on Government Reform

4 concluded that ACIP, quote, Reflects, quote, a

5 system where the government officials make crucial

6 decisions affecting American children without the

7 advice and consent of the governed?

8 A I'm not aware of that report, and --

9 Q I'll give you a copy.

10 A -- I do not agree with it.



13 BY MR. SIRI:

14 Q I'm going to hand you what's being marked

15 as Plaintiff's Exhibit 9. Happy to provide you a

16 copy as well after the deposition that you can take

17 home with you.

18 A I will be interested in reading this. But

19 I would say two things: One is that CDC certainly

20 recently has leant over backwards to try to avoid

21 people with conflicts of interest being on ACIP.

22 And, second, that ACIP meets under

23 public conditions; that is to say, the meeting is

24 open to the public, the meeting is on the web, so

25 that thousands of people, literally, can observe


Page 132


2 what goes on at the meeting and decide for

3 themselves whether or not there's any hanky-panky.

4 So although, as I said before, I

5 might wish that people with more knowledge about

6 vaccines be on the ACIP, by and large I think that

7 they do a hell of a good job under public scrutiny.

8 Q Are the working groups, are those also

9 public?

10 A They are not public in the sense that the

11 public does not attend the working group. The

12 working group does report back to the full ACIP, and

13 the working group's presentations are presented

14 publicly.

15 Q But the discussions that the working

16 groups have in conference calls leading up to ACIP

17 meetings, those are not transcribed, are they?

18 A They are not, no.

19 Q Okay. And the members and individuals who

20 participate in those working groups, right, which

21 often lead to what ACIP then rubber-stamps, are

22 permitted to have all forms and do have all forms of

23 conflicts with industry, don't they?

24 A They may. But I would contest the word

25 "rubber-stamp." I've never seen the ACIP


Page 133


2 rubber-stamp a working group recommendation. Often

3 it's just the opposite.

4 Q You've also, you've also said that the

5 meetings are available to the public. You've

6 attended, you said, almost every ACIP meeting,

7 correct?

8 A Correct.

9 Q Since, when was it, the '60s?

10 A Yeah. Roughly, yes.

11 Q And you attended the most recent one as

12 well?

13 A The most recent one being -- let's see.

14 That would have been last October. Yes, I did.

15 Q Were you presented anything at that

16 meeting?

17 A I presented the fact that I will no longer

18 attend the meetings.

19 Q Were you presented anything by the ACIP

20 committee?

21 A Yes.

22 Q What were you presented?

23 A I was presented -- well, I was told that

24 there is a gavel with my name on it, that it will be

25 used henceforth at the meetings.


Page 134


2 Q And they gave, so going forward, from this

3 point forward, the gavel that's used at ACIP will

4 have your name on it?

5 A Correct.

6 Q You gave a speech at that meeting,

7 correct?

8 A Yes.

9 Q When they posted the video of that meeting

10 on the Internet, did they include your speech,

11 Dr. Plotkin?

12 A I don't know, but I suppose they did.

13 Q Well, you can check after this deposition

14 on the website and see if your speech is there. I,

15 we have not been able to find it.

16 A Really? Wow. Too bad.

17 Q Regularly at ACIP meetings, you get up and

18 speak, correct?

19 A I often do, yes.

20 Q So you're given free, you're able to get

21 up pretty much at any time and speak, aren't you?

22 A Yes. Umm --

23 Q You don't have to wait for the public

24 comment period, correct?

25 A Correct.


Page 135


2 Q And that's also true of vaccine

3 manufacturers; they also are permitted to get up and

4 come to the mic and speak even not -- when there

5 isn't public --

6 A Yes. They're often asked to answer

7 questions that are being discussed.

8 Q Isn't it true that they also get up and

9 come to the front to speak even when not asked a

10 question?

11 A They may do so if they have, if it's a

12 discussion about one of their products.

13 Q But if members of the public want to

14 speak, they have to wait until the public speaking

15 period, correct?

16 A Normally, yes.

17 Q And when the videos are released, a lot of

18 the conversations that occur between the

19 pharmaceutical representatives and ACIP, do those

20 also make it to the video that's released publicly?

21 A As far as I know, the video contains all

22 of the public hearings. In other words, if somebody

23 comes to the mic, they are photographed; and as far

24 as I know, they appear on the web.

25 I must say that since I've been


Page 136


2 attending the meetings, I haven't really watched

3 them; but I will in February when they meet again.

4 Q So apart from the working groups that

5 occur out of public sight, what other meetings or

6 goings-about does ACIP engage in that's outside of

7 the scrutiny of the public?

8 A Aside from working groups, I'm not aware

9 that they do have anything that's not public. I

10 suppose they meet at lunchtime, and I don't attend

11 those discussions. But that's all I know.

12 Q Billions of dollars' worth of rotavirus

13 vaccine have been sold to date, correct?

14 A I believe so. I'm not acquainted with the

15 sales figures.

16 Q Does vaccination create a systemic change

17 in the body?

18 A Vaccination creates a change in the immune

19 system of the body.

20 Q Is that supposed to be system-wide,

21 meaning if I get vaccinated in my arm but I'm

22 infected in my toe, am I still supposed to still be

23 immune?

24 A Yes.

25 Q So would you say, is it correct to say


Page 137


2 that vaccination is intended to create a systemic

3 change in the body, throughout the body?

4 A It's intended to create a systemic change

5 in the immune system of the body.

6 Q In the immune system everywhere in the

7 body?

8 A The immune system is expressed everywhere

9 in the body. Yes. The immune system consists of

10 antibody-producing cells and cells that are able to

11 influence other cells.

12 Q So the -- can you read back the last

13 answer.

14 - - -




18 "A. The immune system is

19 expressed everywhere in the

20 body. Yes. The immune system

21 consists of antibody-producing

22 cells and cells that are able to

23 influence other cells.")

24 BY MR. SIRI:

25 Q Okay. Does the immune system comprise of


Page 138


2 more than antibody-producing cells?

3 A It also has, also includes what are called

4 T cells that are able to kill infected cells, for

5 example, and to secrete substances that also have an

6 effect on immunity.

7 Q Is that referred to typically as cellular

8 immunity?

9 A Yes.

10 Q And the immunity conferred by vaccines

11 that you were talking about earlier is called --

12 A Humoral immunity, yes.

13 Q Thank you. Appreciate that. Humoral

14 immunity?

15 A Yes.

16 Q Okay. So humoral immunity creates

17 antibodies, and it's called humoral because it

18 originates from the bones? Is that kind of where

19 the name derives from?

20 A Well, the name derives from the ancient

21 term "humors." But, in effect, it means antibodies

22 that circulate throughout the body and can impact

23 against infecting organisms.

24 Q And the systemic change that you've

25 described is supposed to last years, if not a


Page 139


2 lifetime --

3 A Yes.

4 Q -- correct, from vaccination?

5 A Yes.

6 Q When you say "interact with other cells,"

7 when you say that the immunity created by vaccines

8 creates antibodies which then interact with other

9 cells, can you describe that a bit more? What do

10 you mean by "interact with other cells"?

11 A Well, the T cells, as I said, are able to

12 attack infected cells in the body by a variety of

13 mechanisms. They may actually directly kill those

14 infected cells by direct action, as it were, or by

15 secreting substances that can kill the cells.

16 And they also influence cells to

17 respond to the infection so that the infection

18 doesn't continue to spread and impact on the

19 individual's health.

20 Q And how do the cells respond to the

21 infection? Can you describe that?

22 A You mean the patient's own cells?

23 Q I thought that's what you were referring

24 to in your explanation.

25 A Yeah. The T -- the -- do you mean the


Page 140


2 infected cells or the T cells that are acting on the

3 infected cells?

4 Q Let's start with the T cells.

5 A Well, the T cells, as I've said, have a

6 variety of functions. They can secret substances

7 that will kill an infected cell, or they can

8 influence actually the antibody-producing system.

9 They have impacts on a variety of ways in which the

10 body protects itself against infection.

11 There are cells called natural killer

12 cells, for example, that can help protect an

13 individual against an infection. And the T cells

14 can influence the natural killer cells.

15 So it's a complicated system by which

16 the body responds to an infection or to a vaccine

17 which allows the individual cells to be ready for an

18 infection if it occurs.

19 Q Modern immunology, though, doesn't fully

20 understand that full cascade, correct?

21 A I'm sorry.

22 Q I said modern medicine, modern immunology,

23 does not fully understand the complete sequence of

24 events in terms of going from vaccination to

25 immunity, correct?


Page 141


2 A Well, science never completely understands

3 anything. But we know a great deal about how the

4 body responds to vaccines or to infection, and that

5 knowledge is growing every day.

6 So, of course, we don't completely

7 understand anything, including how the sun works.

8 But that doesn't prevent us from using knowledge.

9 Q What about its effects on other body

10 systems? Can creating this immune response also

11 have effects not only on creating antibodies to

12 target cells that have been infected, but can it

13 also have other bodily changes, other effects that

14 are either known or unknown?

15 A That's such a hypothetical question; I'm

16 not sure how to answer it. Is an immunized

17 individual any different than an unimmunized

18 individual?

19 Yes.

20 Does the fact that the individual is

21 immune have an effect on his or her general health?

22 I'm not aware that that's the case.

23 Remember that vaccines are, in

24 effect, mimicking what happens after natural

25 infections in many cases, but without causing the


Page 142


2 complete range of disease that the organism causes.

3 Q So vaccines are just nothing more than a

4 piece of the virus or bacteria; is that it? Is that

5 all they contain?

6 A Depends on the vaccine. The, that is to

7 say, whether it's a live vaccine or a killed

8 vaccine. The killed vaccines may only have small

9 parts of the organism that they're protecting

10 against. The live vaccines contain the whole

11 organisms but altered so that they don't cause

12 disease.

13 Q Before vaccines are licensed, they go

14 through clinical trials to confirm their safety,

15 right?

16 A Correct.

17 Q These clinical trials assess if there are

18 any harms caused by the vaccine, correct?

19 A Yes.

20 Q Was the DTP vaccine withdrawn from the

21 U.S. market?

22 A The whole-cell --

23 Q The DTP --

24 A -- pertussis vaccines have been withdrawn,

25 yes.


Page 143


2 Q Because of safety concerns, right?

3 A Because they cause significant fever and

4 convulsions, febrile seizures. And they were, it

5 was decided that it would be better to have a

6 pertussis vaccine that didn't cause that type of

7 reaction. So they were taken off the market, not

8 because they were not working; quite the opposite,

9 but because of safety concerns.

10 Now, I do have to point out that

11 aside from the U.S. and Europe, whole-cell pertussis

12 vaccines are still used in the vast majority of

13 countries in the world, and they are getting along

14 just fine with those vaccines.

15 Q Are you familiar with Peter Aaby,

16 Dr. Peter Aaby?


18 Q Didn't he recently publish a paper in

19 which he looked at children who received DTP vaccine

20 in the first six months of life versus children who

21 received no vaccines in the first six months of life

22 and found that those that received DTP died at a

23 rate of ten times that of the unvaccinated?

24 A I don't remember the exact figures. But

25 you have to take into account that Peter Aaby -- I


Page 144


2 had many discussions with Peter Aaby. Peter Aaby's

3 work is done in a, in non-placebo-controlled ways;

4 that is, his studies are observational.

5 Second point is that those studies

6 have been examined more than once by World Health

7 Organization committees. And their judgment has

8 been that the effects of the pertussis vaccine in

9 particular are not sufficiently documented to be

10 acceptable or to change vaccination practice.

11 So WHO does not recommend against the

12 use of whole-cell pertussis vaccines; quite the

13 opposite. They do recommend them.

14 Q You said non-placebo-controlled. What do

15 you mean?

16 A I mean that essentially what Peter does --

17 and I'm not criticizing him because obviously it is

18 very difficult to do, but he doesn't have randomly

19 vaccinated or children who randomly receive

20 pertussis vaccine or don't receive pertussis

21 vaccine.

22 What he has is, he follows children

23 who have received this or that or the other vaccine

24 and tries to draw conclusions from what he sees.

25 But in the absence of random administration, you


Page 145


2 don't know for sure whether it's the vaccine or

3 other factors that are operating.

4 Q So in the study that I mentioned to you,

5 if the children either were exposed to DTP and

6 unexposed were randomized, that would make the study

7 valid?

8 A Yes. And, again, the WHO has at least

9 twice gone over Peter's studies and has decided that

10 they are not of sufficient proof to change their

11 recommendations.

12 Q Do you have a copy of those reports from

13 the WHO?

14 A Oh, gosh.

15 MR. SIRI: Because I'm going to make a

16 demand for those WHO reports.

17 BY MR. SIRI:

18 Q Do you remember when those reports came

19 out?

20 A Within recent years. I don't remember the

21 year.

22 Q More than a year ago?

23 A Probably, yes.

24 Q Peter Aaby's study just came out last

25 year?


Page 146


2 A Well, I imagine WHO will reconsider them.

3 But his studies suggesting that pertussis may,

4 vaccine may increase mortality have been around for

5 a while. It's not the first study that he's done.

6 Also, one has to appreciate the

7 context. By that I mean that he's also shown or

8 attempted to show that live vaccines like measles

9 vaccine has a very positive effect on mortality; in

10 other words, that in his observations, those who

11 received measles vaccine suffer from fewer diseases

12 in general and have a lower mortality. And that

13 effect has actually been confirmed immunologically.

14 So one has to look at the whole

15 context of things; that is to say, his data are not

16 anti-vaccine data. His data relate to the

17 possibility that vaccines have effects beyond the

18 specific disease that they're designed for.

19 Q So you agree with his findings regarding

20 live vaccines?

21 A I agree because, as I've said and as I

22 advised him years ago, that he has to find some

23 immunological correlate to his findings or,

24 otherwise, they're not believable.

25 And what's happened is that


Page 147


2 scientists not working with Peter have looked at

3 measles vaccination and have shown that the vaccine

4 has effects on what I referred to as natural killer

5 cells before and that they do seem to reduce

6 mortality against other diseases.

7 So, you know, science works that way.

8 One scientist does not gain acceptance for his

9 findings unless they're repeated elsewhere and

10 unless they're consistent with the entire range of

11 facts, not just single ones.

12 Q Peter Aaby's a respected researcher,

13 correct? He's a respected researcher, correct?

14 A He's a respected researcher. I respect

15 him, just as I respect many other scientists who are

16 attempting to find out things that we don't know

17 yet.

18 Q In conducting prelicensure clinical trials

19 for vaccines, what is the difference between

20 solicited and unsolicited reactions?

21 A Well, solicited reactions means that you

22 ask the vaccinee whether he's had X, Y or Z.

23 Unsolicited are reactions that the patient reports

24 to the investigator without being specifically

25 questioned about them.


Page 148


2 Q Who decides what gets put on the solicited

3 list and what's -- who decides what symptoms get put

4 on the solicited list of reactions?

5 A Well, generally the investigator; however,

6 one has to take into account that the companies meet

7 with FDA during the development of vaccines and that

8 FDA basically has to approve the protocols. And so

9 if FDA thinks that a particular reaction should be

10 measured, they will tell the investigators to

11 include them.

12 Q But the list is created by the

13 pharmaceutical company developing the vaccine?

14 A In the first instance, yes, and then

15 approved by the FDA.

16 MR. SIRI: Let's take a two-minute break.

17 VIDEO OPERATOR: We are going off the

18 record. The time is 11:50.

19 (Lunch recess.)


21 Tape No. 3 in the deposition of Stanley


23 12:37.

24 BY MR. SIRI:

25 Q Dr. Plotkin, earlier you testified that


Page 149


2 there are two hep B vaccines on the market. One by

3 Glaxo, GSK, that's Endrix-B; and the other one is by

4 Merck, Recombivax HB, right?

5 A Yes.

6 Q For the Recombivax HB, how long was the

7 safety review period in the prelicensure clinical

8 trial for this vaccine?

9 A I don't know.

10 (Exhibit Plaintiff-10 was

11 marked for identification.)

12 BY MR. SIRI:


14 been labeled Plaintiff's Exhibit 10. This is the

15 product, the manufacturer insert for Recombivax HB,

16 correct?

17 A Yes.

18 Q And the clinical trial experience would be

19 found in Section 6.1, correct?

20 Correct? Dr. Plotkin?

21 A Yes.

22 Q In Section 6.1, when you look at the

23 clinical trials that were done prelicensure for

24 Recombivax HB, how long does it say that safety was

25 monitored after each dose?


Page 150


2 A Five days.

3 Q Is five days long enough to detect adverse

4 reactions that occur after five days?

5 A No. They would be --

6 Q Is it --

7 A They would be reported separately as

8 observed in the clinic.

9 Q In Section 6.1 of the manufacturer insert,

10 which under the Code of Federal Regulations are

11 supposed to describe the clinical trial, does it

12 provide for anything other than five days of

13 monitoring after each dose for adverse events?

14 A It does not specifically say that, no.

15 Q Okay. Is five days long enough to detect

16 an autoimmune issue that arises after five days?

17 A No.

18 Q Is five days long enough to detect a

19 seizure that arises after five days?

20 A It would be unlikely to have a seizure

21 occur after five days.

22 Q Is five days long enough to detect any

23 neurological disorder that arose from the vaccine

24 after five days?

25 A No.


Page 151


2 Q Was there any control group in this trial?

3 Let me rephrase that.

4 There's no control group, correct?

5 A Not -- let's see.

6 Well, they mention 3,258 doses were

7 administered to 1,252 healthy adults.

8 Q That's right. But does it mention any

9 control group, Dr. Plotkin?

10 A It does not mention any control group, no.

11 Q If you turn to Section 6.2, what is the

12 list of adverse reactions listed in this section?

13 A These are reports of adverse reactions

14 that likely were reported to the VAERS system.

15 Q Under immune system disorders, does it say

16 that there were reports of hypersensitive reactions,

17 including anaphylactic, anaphylactoid reactions,

18 bronchospasms, and urticaria having been reported

19 within the first few hours after vaccination?

20 A Yes.

21 Q Have there been reports of

22 hypersensitivity syndrome?

23 A Yes. That's what it states.

24 Q Does it, reports of arthritis?

25 A It is mentioned.


Page 152


2 Q There are also reports of autoimmune

3 diseases, including systemic lupus, erythematosus,

4 lupus-like syndrome, vasculitis, and polyarteritis

5 nodosa as well, correct?

6 A Yes. That's what it states.

7 Q And also it states that, under the nervous

8 system disorders, it states that after that, there

9 have been reports of Guillain-Barré syndrome?

10 A Yes.

11 Q As well as multiple sclerosis,

12 exacerbation of multiple sclerosis; myelitis,

13 including transverse myelitis; seizure, febrile

14 seizure; peripheral neuropathy, including Bell's

15 palsy; radiculopathy --

16 A Radiculopathy.

17 Q Thank you very much.

18 -- muscle weakness, hypesthesia, and

19 encephalitis, correct?

20 A Correct.

21 Q Okay. Now, it says at the top --

22 A Before you go on, these reports are

23 required to be included because they have been

24 reported to the authorities as happening after

25 vaccination. That is not proof that the vaccine


Page 153


2 caused those reactions, because things happen to

3 people all the time, whether or not they've been

4 vaccinated. And as I've said, the company is

5 required to report these.

6 Now, I mention that specifically

7 because multiple sclerosis, for example, is

8 mentioned here. Multiple sclerosis has been studied

9 in relation to hepatitis B vaccine, and there's no

10 relationship, no causal relationship.

11 So the fact that these things are in

12 the package circular does not mean that the vaccine

13 necessarily caused the stated phenomena.

14 Q When you say that multiple sclerosis has

15 been studied and is determined to not have been

16 caused, you're talking about the 2011 IOM report, I

17 assume?

18 A I'm talking about studies mostly done in

19 France where the situation arose where there was a

20 concern about that.

21 Q You're aware of the 2011 IOM report that

22 looked at certain vaccines in relation to whether

23 they can cause certain adverse reactions?

24 A Yes.

25 Q Are you aware that one of those conditions


Page 154


2 they looked at was multiple sclerosis?

3 A Among others, yes.

4 Q Among others. And that they specifically

5 looked at it with regards to hepatitis B?

6 A Yes.

7 Q And do you know what their finding was?

8 A I don't remember the exact wording, no.

9 Q Maybe this will remind you: Inadequate to

10 accept or reject a causal relationship.

11 They didn't know, correct?

12 A Yes. Yes. But you have to understand,

13 first of all, that science continues and so studies

14 continue. And secondly, that the IOM specifically

15 decided that they would not draw a conclusion if

16 they weren't sure of the conclusion.

17 So what that statement means is that

18 they don't have data that confirm that multiple

19 sclerosis is caused by the hepatitis B vaccine and

20 they, that they don't regard that they have enough

21 data to positively exclude it. So you cannot read

22 that as saying that multiple sclerosis is caused by

23 hepatitis B vaccine.

24 Q I never said that. The IOM did for some

25 of the vaccines and adverse reactions, did conclude


Page 155


2 that it favors rejection of a causal relationship,

3 correct?

4 A Yes, that's correct.

5 Q But it didn't reach, sorry, it didn't

6 reach that conclusion for hepatitis B and multiple

7 sclerosis, correct?

8 A It did not reach that conclusion.

9 Q Okay.

10 A But other data suggests that that

11 conclusion is warranted, that there is no

12 relationship.

13 MR. SIRI: Well, I'll make a demand for

14 that. You can produce that after this

15 deposition.

16 BY MR. SIRI:

17 Q What would need to be done to -- in order

18 to know whether or not any of these reported

19 conditions are caused by the vaccine, what you would

20 need is a properly randomized, as you've said

21 earlier, placebo-controlled study, correct?

22 A Correct.

23 Q Okay.

24 A And, also, I would point out that multiple

25 sclerosis is a disorder of adults, and the issue


Page 156


2 that arose in France was related to vaccination of

3 adults.

4 Q Okay.

5 A There, that does not mean that it would be

6 an issue, even if it were an issue, for children.

7 Q Dr. Plotkin, I was just asking what it

8 says on there. There's lots of conditions listed.

9 I'm not saying that multiple sclerosis is caused by

10 this. I'm just asking if it's listed on

11 Section 6.2.

12 In fact, we can even read the top of

13 Section 6.2 which says: The following additional

14 adverse reactions have been reported with the use of

15 the marketed vaccine. Because these reactions are

16 reported voluntarily from a population of uncertain

17 size, it is not possible to reliably estimate their

18 frequency or establish a causal relationship to a

19 vaccine exposure, right?

20 A Correct.

21 Q Okay. So that's what it says right at the

22 top of 6.2?

23 A Mm-hmm.

24 Q But these are events that are reported

25 after vaccination. And as you've just, we just


Page 157


2 discussed, in order to establish whether it's causal

3 between the vaccine and the condition, you need a

4 randomly, a randomized, placebo-controlled study?

5 A Yeah.

6 Q But that was not done for this hepatitis B

7 vaccine before licensure, was it?

8 A No.

9 Q Okay. And given that the vaccine now

10 appears on the CDC's recommended list, isn't it true

11 that it would now be considered unethical to conduct

12 such a study today?

13 A It would be, yes, it would be ethically

14 difficult.

15 Q So let's take a look at Engerix-B. That's

16 the other the hepatitis B vaccine that you testified

17 that you recommend Faith receive.

18 Do you know how long adverse

19 reactions were reviewed after each dose of that

20 vaccine in the prelicensure clinical trial?

21 A Not offhand, no.



24 BY MR. SIRI:

25 Q I'm going to hand you what has been marked


Page 158


2 Plaintiff's Exhibit 11. This is the manufacturer

3 insert for the Engerix-B, correct?

4 A Yes.

5 Q Okay. If you turn to Section 6.1, which

6 is clinical trials experience, can you please tell

7 me how long the safety review period was in the

8 prelicensure clinical trials after each dose?

9 A All subjects were monitored for four days

10 post administration. That does not necessarily mean

11 that they didn't collect reactions after four days.

12 Q Are you claiming they collected reactions

13 after four days but didn't disclose it here in

14 violation of the Code of Federal Regulations?

15 A I daresay that they collected putative

16 reactions for a longer period. I feel quite

17 positive about that. When they say they were

18 monitored for four days, that means active

19 monitoring as opposed to collecting reports later

20 on.

21 That is not uncommon in clinical

22 trials.

23 Q Is four days long enough to detect an

24 autoimmune issue that arises after four days?

25 A No.


Page 159


2 Q Or a neurological disorder that arises

3 after four days?

4 A No. That would be reported later.

5 Q Uh-huh. And can you provide any proof

6 that there was any reports or follow-up after those

7 four days?

8 A Well, it doesn't say that here, but I am

9 willing to bet that they did collect reactions after

10 four days. And I imagine that the FDA would not

11 have allowed them not to do that.

12 Q But as you sit here today, that's just

13 speculation, correct?

14 A Yes, that's speculation based on

15 experience.

16 MR. SIRI: I'm going to make a request for

17 you to provide proof of what you're claiming,

18 that there was actually, for both hepatitis B

19 vaccines, any safety review that occurred after

20 four days of administration of any dose of

21 these vaccines.

22 MS. NIEUSMA: Again, I'm going to continue

23 the objection, I guess, from last time since we

24 took a longer break. There's a proper

25 procedure to request documents in discovery.


Page 160


2 He doesn't have to come back and produce it.

3 MR. SIRI: Objection's noted. Thank you.

4 BY MR. SIRI:

5 Q So, and there's no, there was no placebo

6 group, correct? In the 13,000, in the trial at the

7 top where it talks about 13,000 doses being

8 administered.

9 A It does not say that there was a control

10 group. I don't know. I'd have to go back and look

11 at the study.

12 Q And do you believe, so you think there --

13 but you're just speculating that there might have

14 been a control group?

15 A There well might have been. It's not

16 unusual for controls to be included, especially if

17 you're looking at reactions. But I don't know

18 specifically for this study.

19 Q If you're claiming there might have been a

20 control group, then please do provide support for

21 that, because as far as I understand, the

22 manufacturer -- and this was -- who makes Engerix-B?

23 Glaxo? One of your clients.

24 If there was a control group, they

25 needed to have disclosed that. And I assume they're


Page 161


2 not disclosing it because there was none.

3 A Well --

4 Q Go ahead.

5 A All right. Go ahead.

6 MS. RUBY: Ms. Nieusma, are you still

7 there?

8 MS. NIEUSMA: Yes. My headset died, but I

9 called back in. So I didn't -- I don't think I

10 missed much. Are you still going over the

11 insert?

12 BY MR. SIRI:

13 Q So let's go back to section, now

14 Section 6.2 on this manufacturer insert for

15 Engerix-B. It talks about the post-marketing

16 experience for this vaccine. This one lists for

17 immune disorders, immune system disorders that were

18 reported, a whole number of them, correct?

19 A Mm-hmm.

20 Q And it also lists a number of nervous

21 system disorders, including encephalitis,

22 encephalopathy, migraine, multiple sclerosis,

23 neuritis --

24 A Mm-hmm.

25 Q -- neuropathy, paresthesia -- I'll ask the


Page 162


2 question all the way at the end. Guillain-Barre

3 syndrome, Bell's palsy, optic neuritis, paralysis,

4 paresis, seizures, syncope, and transverse myelitis,

5 correct? It lists all of those?

6 A Yes.

7 Q Okay. But to know whether or not these

8 are actually caused by Engerix-B, again, you would

9 need a properly randomized, placebo-controlled

10 study, correct?

11 A Correct.

12 Q But this study wasn't done prelicensure

13 for this vaccine, right?

14 A I'd have to go back and look at the

15 original studies. But these data, undoubtedly,

16 refer not only to the study that was done before

17 licensure, but also to phenomena reported after

18 licensure.

19 Q That's 6.2. Okay. And, again, given this

20 vaccine now appears on the CDC's recommended list,

21 it would be unethical to do a randomized,

22 placebo-controlled study of this vaccine, right?

23 A In children it would be unethical. It

24 could be done in adults.

25 Q Now, if you please go to page 11 of this


Page 163


2 same manufacturer insert for the hepatitis B, if you

3 take a look over there, I think you'll find that it

4 provides that there was a follow-up with regard to

5 efficacy, not safety, efficacy, that was beyond the

6 four days?

7 A Yeah.

8 Q Do you see there was a 12-month and an

9 18-month follow-up?

10 A Yes.

11 Q So just to be clear, efficacy of the

12 vaccine was followed up for at least 12 months or

13 18 months, but safety was only done for four or five

14 days?

15 A I do not agree with that statement.

16 Q Okay.

17 A I do believe that GSK, like any other

18 company, would have followed their patients much

19 longer than four days and would have collected

20 reaction data.

21 Q And if they didn't do that, you would

22 agree that that is completely inadequate in terms of

23 assessing safety prelicensure?

24 A I would say that would be inadequate, yes.

25 Q Do you agree with the CDC's recommendation


Page 164


2 that babies receive a hepatitis B on the first day

3 of life?

4 A Yes.

5 Q And these are, the Engerix-B and

6 Recombivax HB are the only two hepatitis B vaccines

7 approved for one-day-old babies, correct?

8 A Correct. "And why is that?" you may ask.

9 It is because if the baby is not vaccinated --

10 Q I didn't.

11 A Well, I'm telling you that if the baby is

12 not vaccinated at one day of age, transmission may

13 occur from an infected mother. And the hepatitis B

14 occurring in babies is likely to become chronic and

15 to cause serious disease later in life. That's why

16 the dose is given at one day of age.

17 Q I'm not, I wasn't asking you any questions

18 about efficacy or why it's done.

19 A I'm telling you that's why it's given.

20 Q Thank you. But, obviously, I'm just

21 trying -- like any product, obviously, you want to

22 have informed consent to understand the risks and

23 benefits. I'm just trying to understand what was

24 done prelicensure for these vaccines. I think

25 you've explained that to me.


Page 165


2 One of the things you said in the

3 past and I believe is that without clinical trials,

4 without a control group in a clinical trial, you're

5 in la-la land, right? You said that one time? Do

6 you recall?

7 A Without a control group, if you're looking

8 for a phenomenon occurring in the vaccine group, you

9 cannot judge that phenomenon without having a

10 control group.

11 Q There's only one standalone polio vaccine

12 currently licensed in the United States, correct?

13 A Well, as far as licensure, I think both

14 oral and inactivated vaccines are licensed. But the

15 only one that is used in the U.S. currently is the

16 inactivated one.

17 Q IPV?

18 A Yes.

19 Q Right. And there's only one company --

20 Sanofi, there's only one, IPOL by Sanofi?

21 A Yes.

22 Q A vaccine -- strike that.

23 How long was the safety review for

24 each dose of IPOL in the preclinical trials for that

25 vaccine?


Page 166


2 A I do not know offhand. But, Counselor,

3 IPV has been used throughout the world for years in

4 millions of people, and safety data have been

5 collected on many such studies. And essentially,

6 serious reactions to IPV are extremely rare. So IPV

7 is a very safe vaccine.

8 Q I'm asking you in the prelicensure

9 clinical trial for --

10 A That goes back to Jonas Salk where he --

11 well, he, where millions of children actually were

12 vaccinated with IPV back in the '50s.

13 Q And is there clinical trial data on

14 safety?

15 A Yes.

16 Q Is that the same vaccine that's used

17 today?

18 A Yes.

19 Q Are you prepared to produce that clinical

20 data?

21 A Those data are in this book, and I'll be

22 glad to provide you with the references if you

23 really insist. But IPV, as I've said, has been used

24 in millions and millions of people.

25 Q If it's so safe, then how come the safety


Page 167


2 review period for the prelicensure clinical trial as

3 provided in the manufacturer insert for IPOL only

4 reviewed safety for 48 hours?

5 A Once again, I have no doubt that safety

6 observations were made after 48 hours, but they

7 expected that immediate reactions, such as a sore

8 arm or fainting or something like that, would have

9 happened within 48 hours.

10 And, also, I'm sure that they're

11 talking about their own specific production of IPV

12 and not relying on the millions of other people who

13 have been vaccinated with IPV.


15 as Exhibit 12. This is the manufacturer insert for

16 the IPOL polio virus vaccine inactivated.



19 BY MR. SIRI:

20 Q If you could please turn --

21 A So let's --

22 Q -- to Section 6.1, Dr. Plotkin. This is

23 an older one. If you could turn to the adverse

24 reactions, which is on page 12, 14.

25 MS. NIEUSMA: I'll preserve the objection.


Page 168


2 To my understanding, Dr. Plotkin had no role in

3 study design. You're asking him to speculate

4 as to the reasoning of other people that he had

5 no contact with.

6 MR. SIRI: Okay. He's testifying that my

7 client should receive this vaccine. I can

8 certainly ask him about the prelicensure

9 clinical trials that were done to assess its

10 safety. And you've put him up as an expert in

11 vaccinology. But your objection is noted and

12 preferred for the record.

13 Thank you, Counselor.

14 BY MR. SIRI:

15 Q Okay. So if you go to page 14,

16 Dr. Plotkin, how long does it say that adverse

17 reactions were observed after vaccination?

18 A Forty-eight hours.

19 Q Okay. And did the subject group that

20 received IPV only receive IPV or did they receive

21 another vaccine along with it?

22 A Concurrently with DTP.

23 Q And what did the control group receive?

24 A I don't see that stated.

25 Q If DTP is given along with IPV, how could


Page 169


2 you know whether a reaction was caused by DTP or

3 IPV?

4 A You could not.

5 Q Okay. If you --

6 A However, they do say these systemic

7 reactions were comparable in frequency and severity

8 to that reported for DTP given alone without IPV.

9 Q And DTP was the vaccine we talked about

10 earlier that was withdrawn from the market,

11 correct --

12 A Yes.

13 Q -- for safety issues?

14 The only MMR vaccines available in

15 the United States are made by Merck, correct?

16 A Correct.

17 Q How long was the safety review -- do you

18 know how long the safety review period for each dose

19 of MMR in the prelicensure clinical trials for this

20 vaccine?

21 Do you know how long the safety

22 review period for each dose of MMR in the

23 prelicensure clinical trial was for this vaccine?

24 A Not offhand. The vaccine has only been

25 used now for about 50 years.


Page 170


2 Q So it's more recent, right?

3 A (No response.)





8 BY MR. SIRI:

9 Q This is the manufacturer insert for MMR

10 II, correct?

11 A Yes.

12 Q If you go to the precaution section, I'm

13 sorry, the adverse reaction section, I apologize, on

14 page 6, what you'll find is that there was no

15 clinical trial prior to licensure for MMR, correct?

16 A I doubt very much that's the case.

17 Q You're not aware that it's -- is it -- are

18 you aware that it is a grandfathered product?

19 A I am not aware that it's grandfathered. I

20 was alive and well when the product was first

21 licensed, and it was tested extensively before it

22 was licensed.

23 Q So --

24 A So to say that it hasn't been tested is

25 absolute nonsense.


Page 171


2 Q How come there's no clinical trial data in

3 the manufacturer insert?

4 A That is something that the FDA would have

5 decided isn't necessary.

6 Q Are you willing to --

7 A But we're talking about a vaccine that's

8 been given to millions of children. And just -- I

9 insist on this point, that measles is now a

10 relatively rare disease in the United States because

11 most children receive measles, MMR vaccine.

12 However, in the last, since 2000,

13 because of children who have not been vaccinated,

14 there have been five cases of measles -- I'm sorry,

15 24 cases of measles encephalitis and three deaths

16 caused by measles itself. So --

17 Q Dr. Plotkin, we'll get to that piece of

18 this, but right now I'm trying to talk to you about

19 the prelicensure clinical safety --

20 A What I'm telling you is millions of

21 doses --

22 Q I understand that.

23 A -- have been used of this vaccine --

24 Q I understand you want to --

25 A -- and that there was prelicensure


Page 172


2 trials --

3 Q Okay.

4 A -- which I am absolutely confident about.

5 Q Okay.

6 A You're talking about stuff that's in a

7 package circular that the FDA has approved and full

8 knowledge that safety and efficacy have been

9 demonstrated.

10 Q So you're saying there were clinical

11 trials before the MMR was licensed --

12 A Absolutely.

13 Q -- is that correct?

14 And can you provide those?

15 A You can find them in this book, if you

16 wish.

17 Q So you're saying you won't provide them?

18 A Well, yes, I guess I am saying I won't

19 provide them. If you want to take the trouble, read

20 the book.

21 Q Sitting here today, when did these, can

22 you tell me what year these clinical trials

23 occurred?

24 A Yes. Yes. They were done in the 1960s

25 and the 19 -- yes, mainly in the 1960s.


Page 173


2 Q So you're claiming something happened, but

3 you're not willing to provide any proof that it

4 happened?

5 A The proof is in the publications which you

6 can read --

7 Q Can you please turn to the page where it's

8 in there?

9 MR. SIRI: I'd like to note for the record

10 that Dr. Plotkin has been reading from his

11 notes as well as looking through a book

12 entitled Plotkin Vaccines, Seventh Edition.

13 THE WITNESS: So on pages -- let's see.

14 Between pages 592 and 600, including tables

15 that show the antibody responses, proportion of

16 children with fever and rash after measles

17 vaccine, et cetera, and the numerous references

18 which go with this chapter.

19 BY MR. SIRI:

20 Q So which, are you saying that that was a

21 prelicensure clinical trial --

22 A Yes.

23 Q -- that you just read from?

24 A Yes. But, again, I insist the

25 prelicensure or post licensure, the fact remains


Page 174


2 that the vaccine has been studied extensively over a

3 period of 50 years.

4 Q I know -- I understand you want us to just

5 take your word for it, but I prefer to rely on

6 science, peer-reviewed publications and clinical

7 trials.

8 A That's what you'll find in there.

9 Q So, you know, I understand that you're

10 getting a little upset about me trying to ask for

11 the data, but that's -- I'm just trying to get to

12 the substance. The FDA requires a clinical trial be

13 on the insert. They're not here. Okay?

14 So let's -- you're saying that this

15 table -- and let me take a look at it. This would

16 have been post licensure, not prelicensure. And it

17 doesn't indicate a placebo group, nor that it was --

18 so I'm not -- this is not a clinical trial, as far

19 as I can tell.

20 Do you have a, can you point me to

21 something that had a placebo group and was

22 prelicensure, please, sir?

23 A I'm not sure of the placebo group. I

24 would have to go back and look at the individual

25 studies. But in terms of prelicensure studies, I am


Page 175


2 absolutely certain that they were done when the

3 measles -- the rubella vaccine I developed was

4 incorporated into MMR.

5 Obviously clinical trials were done

6 before licensure. I'm absolutely certain about

7 that.

8 Q Well, maybe they're not included because

9 they didn't include a placebo group.

10 A They may not have included placebo group,

11 yes.

12 Q So maybe they weren't deemed valid enough

13 to consider a clinical trial?

14 A That's absolutely false because you can

15 certainly collect reactions in individuals who

16 receive the vaccine, for example, fever and seizures

17 and that sort of thing that happen immediately and

18 whether there's an effect on blood cells, et cetera.

19 Those things were definitely done.

20 I'm absolutely certain about that

21 because I was there.

22 Q But there was no control group?

23 A I don't remember there being a control

24 group for the studies that I'm recalling.

25 Q So you don't, so you're not aware of any


Page 176


2 trial that assess safety in MMR with the control

3 group, correct?

4 A I cannot cite such a study offhand. I'd

5 have to go back and look to see whether control

6 groups were included.

7 Q I'm just, we've, we talked earlier that to

8 assess safety, you need a randomized,

9 placebo-controlled study. And my understanding from

10 looking at this insert is that no such study exists.

11 You told me that it's in this chapter, and you

12 assured me it's in there. But you're not citing to

13 anything in there right now.

14 So I'm happy to get a copy from you

15 if you like to provide it after this deposition.

16 Would you like to do that?

17 A I will look.

18 Q Going back to page 6, there are, of the

19 manufacturer insert for MMR, there is an extensive

20 list of adverse reactions that have been reported

21 after licensure of this vaccine by individuals

22 receiving the vaccine, correct?

23 A Yes.

24 Q I'm not going to read through all the ones

25 in the -- because it's a page and a half long, but


Page 177


2 they're extensive. And, of course, we won't know

3 whether or not MMR actually causes any of these

4 unless we have a randomized, placebo-controlled

5 study, correct?

6 A Correct.

7 Q When I say "these," I mean all the adverse

8 reactions listed in the manufacturer insert for MMR

9 on pages 6, 7, and 8, right? You understood that's

10 what I meant?

11 A Yes.

12 Q Okay.

13 A Umm --

14 Q Let me ask you this. Listen, let me ask

15 you this. Maybe you can help clarify, okay? You

16 know what? I'll leave that alone.

17 You also testified that Faith should

18 be vaccinated for Hib, correct?

19 A Yes.

20 Q Okay. Do you know how long the safety

21 review period was for each dose of ActHIB in the

22 prelicensure clinical trials for this vaccine?

23 A Not offhand, no.




Page 178


2 BY MR. SIRI:


4 as Plaintiff's Exhibit 14, Dr. Plotkin. This is the

5 manufacturer insert for ActHIB, correct?

6 A Yes.

7 Q If we go to Section 6.1 which is the

8 clinical trials experience, I believe you'll see it

9 addresses a number of clinical trials that were

10 performed, correct?

11 A Yes.

12 Q What were the safety review periods in

13 these trials?

14 A Forty-eight hours. Yes.

15 Q Actually, you know, if you turn to page 8,

16 Dr. Plotkin, they did one that actually was 30 days

17 long, correct?

18 A Say again.

19 Q I said if you turn to page 8 of the

20 insert, one of the clinical trials they did actually

21 did look at, did do a 30-day follow-up, correct?

22 A Yes.

23 Q Now, I'm going to read you a sentence from

24 the paragraph at the bottom of that page.

25 It says: In study P3206, within 30


Page 179


2 days following any dose, one through three of

3 DAPTACEL plus IPOL plus ActHIB vaccinees, 50 of

4 1,455 -- that's 3.4 percent -- participants

5 experienced a serious adverse event, right?

6 A Yes.

7 Q Now, one way to establish whether or not

8 those adverse events were related to the vaccine was

9 to have a placebo group, a control group receiving

10 an inert substance, correct?

11 A That's one way.

12 Q That's right. But there wasn't a control

13 group here receiving an inert substance, correct?

14 A As far as it says, no.

15 Q Right. And the control group here

16 received other vaccines, correct?

17 A Yes.

18 Q And --

19 A Well, actually, it does appear to be --

20 well, for dose four, anyway -- oh, no, I'm sorry.

21 Excuse me.

22 Q Yeah. It's... It's all right.

23 Anyway, so since there is no placebo

24 group receiving an inert substance, then it's left

25 to the vaccine manufacturer seeking licensure to


Page 180


2 determine whether or not the 50 -- the adverse

3 events that arose are or are not related to the

4 vaccine, correct?

5 A Generally speaking, studies organized by

6 manufacturers or anybody else, for that matter, of

7 vaccines has a safety Board attached to the study.

8 And they evaluate whether they think the reaction

9 was due to the vaccine or not.

10 As it says here, only one of the

11 serious adverse events was attributed to the

12 vaccine, which was a seizure with apnea occurring on

13 the day of vaccination after the first dose, which

14 is, you know, in 7,000 infants and a vaccine that

15 prevents meningitis and other serious diseases is

16 not too bad.

17 Q Let's look at that more carefully. This

18 is out of the, out of 1,455, correct?

19 A Yes.

20 Q And it was 50 children that had a serious

21 adverse event within 30 days, correct? And this --

22 A They had -- let's see. Where is that?

23 Q That's the bottom of page 8.

24 A Yes. But you have to understand what is

25 meant by "a serious adverse event." They try to


Page 181


2 accumulate all things that happen to children in a

3 trial. And when they say it's serious, they mean

4 it's not something like pain in the arm or something

5 that's relatively trivial. And then they evaluate

6 whether or not the serious adverse events could be

7 related to the vaccine or not.

8 And what this says is that only one

9 of those events was attributed to the vaccine.

10 Q That's right. That's exactly what this

11 says.

12 A Yes.

13 Q And you told me that the people that

14 evaluate that is a Board set up by the company, the

15 pharmaceutical company seeking approval, correct?

16 A Yes. They set up the Board, and they

17 choose individuals who are not employees of the

18 company.

19 Q But they choose the individuals, correct?

20 A They choose the individuals, yes.

21 Q Okay. In your experience, Dr. Plotkin, in

22 any given 30-day period, do 3.4 percent of children

23 in this country experience a serious adverse event?

24 A Yes. That's quite possible.

25 Q In your experience, would you expect


Page 182


2 3.4 percent of children receiving a saline injection

3 to experience a serious adverse event within 30 days

4 of receiving the injection?

5 A That's what that means; yes.

6 Q Okay. So 3.4 percent every month, that

7 would mean within three years, every child in this

8 country would experience a serious adverse event,

9 correct?

10 A Yes. That's correct.

11 Q Okay.

12 A But you have to understand that "serious

13 adverse events" mean, for example, that a child

14 develops a respiratory infection during the period

15 of the trial. And then the question is, could that

16 respiratory infection be attributed to the vaccine?

17 And the Board decides whether or not

18 it's likely that a vaccine could cause a respiratory

19 infection two or three weeks after the vaccination,

20 for example.

21 Q Wasn't there recently a study out of

22 Hong Kong in which it was actually one of the few

23 randomized placebo-controlled studies in which some

24 children were, randomly got flu vaccine and others

25 didn't get the flu shot; and those that got the flu


Page 183


2 shot and those who didn't had the same rate of flu.

3 But those who got the flu shot were four times more

4 likely to get certain other respiratory infections?

5 A I have not read that particular study.

6 Q We can get to it later.

7 A But influenza vaccine is a whole story in

8 itself.

9 Q Okay. That's fine. If you haven't read

10 it, that's, you know, we can get to it. I have it.

11 We'll come back to it.

12 Now, there was, there's another Act,

13 there's another Hib vaccine called Hiberix, right,

14 and then -- which was licensed after ActHIB,

15 correct?

16 A Yes.

17 Q And in that clinical trial, they used

18 ActHIB as the placebo to assess safety, correct?

19 A If you say so.

20 Q Okay. The CDC's pediatric schedule, you

21 testified earlier, also includes vaccination for

22 HPV, correct?

23 A Yes.




Page 184




4 BY MR. SIRI:

5 Q Sorry. Handing it to you. This is the

6 manufacturer insert for GARDASIL, correct?

7 A Yes.

8 Q Which is a vaccine against HPV?

9 A Yeah.

10 Q GARDASIL is currently the only HPV vaccine

11 used in -- GARDASIL, I'm going to ask you a question

12 unrelated to what I just handed you for a moment

13 while my co-counsel here sends a copy to opposing

14 counsel.

15 MS. NIEUSMA: You can keep going. I have

16 seen the GARDASIL inserts.

17 MR. SIRI: Okay. Thank you.

18 BY MR. SIRI:

19 Q So GARDASIL is currently the only HPV used

20 in the United States, correct?

21 A I'm not sure whether the GSK vaccine is

22 still being used or not, but GARDASIL is the one

23 that is used mostly in any case.

24 Q Can you please turn to page 8, table nine,

25 of this insert.


Page 185


2 A (Witness complies.)

3 Q Okay. This table reflects girls and women

4 nine through 29 years of age who reported an

5 incident condition potentially indicative of a

6 systemic autoimmune disorder during the clinical

7 trial, correct?

8 A Yes.

9 Q The subjects receiving GARDASIL show a

10 rate of 2.3 percent. All right. So that means

11 2.3 percent of the girls and women in the clinical

12 trial during a six-month period had an incident that

13 indicated a systemic autoimmune disorder, correct?

14 A Yes.

15 Q Okay. And in the AAHS control or saline

16 placebo group, it shows the same rate, correct?

17 A Yes.

18 Q Do you know how many individuals were in

19 the saline placebo group versus the AAHS control

20 group?

21 A Well, it says 9,412.

22 Q That would be the total number for both

23 groups, correct?

24 A No. For the placebo group.

25 Q For the placebo group, correct. But some


Page 186


2 of them received AAHS, and some of them received a

3 saline injection, correct?

4 A Correct.

5 Q Okay. Do you know how many received a

6 saline injection over an AAHS injection?

7 A Don't know.

8 Q Okay. Let's go to page 4, and table one

9 is for girls and table two is for boys. I'm

10 assuming all participants were either girls or boys.

11 If we add up the saline placebo group for the girls

12 and the saline placebo group for the boys, do we get

13 594?

14 A Well, I have to do the arithmetic. But it

15 appears that there were about 5,000, more than 5,000

16 in the AAHS control and about 600 in the saline

17 placebo.

18 Q Right. It's about 594. It's about 600.

19 That's right, right?

20 A Mm-hmm.

21 Q Okay. So if we go back to page 8, the

22 saline placebo group had about five in 600, and the

23 rest of them were AAH control, correct?

24 A Apparently, yes.

25 Q Yeah. What does AAHS stand for?


Page 187


2 A The aluminum adjuvants.

3 Q And I see it's defined here as amorphous

4 aluminum hydro --

5 A Hydroxyphosphate sulfate.

6 Q Right?

7 A Yes.

8 Q Thank you.

9 Which we'll refer to as AAHS or the

10 aluminum adjuvant?

11 A Yes.

12 Q Good?

13 Okay. AAHS is not an inert

14 substance, correct?

15 A Well, it's not saline, if that's what you

16 mean. But they use it as a control because they're

17 trying to make, to determine what the reactions are

18 to the HPV vaccine that contains the aluminum and

19 separating the reactions to vaccine from reactions

20 to the aluminum.

21 Q Let me try and understand that. Are you

22 saying they're trying to determine what the rate of

23 reactions is between the group that gets GARDASIL --

24 A Yes.

25 Q -- with the group that gets the


Page 188


2 aluminum --

3 A Yes.

4 Q -- with the group that gets saline?

5 A Yes.

6 Q So they want to compare between those

7 three distinct groups, correct?

8 A Yes. Mm-hmm.

9 Q Okay. And they did do that in table one

10 and two that we just looked at on page 2 --

11 A Yes.

12 Q -- page 4, correct?

13 A Yes.

14 Q Why is aluminum added to the GARDASIL

15 vaccine or any vaccine?

16 A To increase the immunogenicity of the

17 active part of the vaccine.

18 Q If I may, what you mean is that, if I

19 could use a little more laymen terms, are you saying

20 it's intended to stimulate the immune system to

21 create antibodies?

22 A Yes.

23 Q Would that be correct?

24 A Yes. Not by itself, but by enhancing the

25 response to the vaccine antigens.


Page 189


2 Q The antigens bind to the aluminum?

3 A Yes.

4 Q And the aluminum is persistent?

5 A Yes.

6 Q And it remains in the body such that it

7 continues to present the antigen such that

8 antibodies can be created to it, correct?

9 A Well, at least during the immediate period

10 of vaccination, yes.

11 Q Okay. There is, in fact, a syndrome

12 called autoimmune/autoinflammatory syndrome induced

13 by adjuvants, correct?

14 A That is a debatable point. There's a

15 fellow named Yehuda Shoenfeld, an Israeli, who has

16 pushed this idea for many years, as I think it's

17 fair to say that he has never had acceptance by the

18 larger community of immunologists or

19 rheumatologists.



22 BY MR. SIRI:

23 Q I'm going hand you what is being marked --

24 I'm going hand you what's being marked as

25 Exhibit 16.


Page 190


2 A Yes.

3 Q Are you familiar with this book?

4 A Generally speaking, yes. I can't say I've

5 read it all, no.

6 Q Okay. And it's entitled Vaccines In

7 Autoimmunity, correct?

8 A Yes, correct.

9 Q Okay. And it extensively discusses,

10 it's -- it discusses many autoimmune conditions that

11 the authors believe can be caused --

12 A Yeah.

13 Q -- by vaccine, and in particular by

14 aluminum adjuvants?

15 A I don't know about particularly aluminum

16 adjuvants, but that's one of their arguments.

17 Q Can you please turn to the contributors,

18 which starts on Roman, little Roman numeral nine.


20 Q There are, I think, somewhere around 77

21 contributors listed here. You said that Yehuda

22 Shoenfeld was kind of alone, I think, or something

23 like that with regard to the claim that

24 autoimmune/autoinflammatory syndrome induced by

25 adjuvants.


Page 191


2 A Yes.

3 Q Can you just flip through and look at the

4 universities that are listed here where these over

5 70 professors hail from. Are these respected

6 institutions of medicine around the world?

7 A Well, first of all, Counselor, I have to

8 go over the CVs of each of the people here. You

9 know, I don't know what their role is at the

10 universities. As I said before, Shoenfeld -- first

11 of all, Shoenfeld himself is not anti-vaccination.

12 I know that for a fact.

13 On the other hand, at least one of

14 his co-authors, Tomljenovic, is a well-known

15 anti-vaccination person who has written a lot about

16 how terrible vaccines are. And as far as the

17 articles are concerned, you know, I have to read

18 each one.

19 But, for example, vaccination in

20 patients with autoimmune inflammatory rheumatic

21 diseases, in other words, patients who themselves

22 already have autoimmune diseases, that's a,

23 certainly a legitimate field of study; in other

24 words, how do you vaccinate people who already have

25 autoimmune disease? Could their vaccinations make


Page 192


2 things worse?

3 But that doesn't necessarily mean

4 that the vaccines themselves cause disease. Now,

5 here we have a chapter called "Measles, Mumps, and

6 Rubella Vaccine: A Triad to Autoimmunity," of which

7 Shoenfeld himself is one of the authors. I am --

8 what shall I say? I do not believe there is any

9 solid evidence that measles, mumps, and rubella

10 disease cause autoimmune responses.

11 So, you know, lots of books are

12 published, and a lot of them are absolute bull.

13 Q Are you saying that this book is bull?

14 A I haven't read the whole thing, but I'm

15 almost certain there's a lot of bull in it, judging

16 from the editors.

17 Q Without reading it, right?

18 A Without reading all of it, yes.

19 Q Okay. Are you familiar with the Tel Aviv

20 Sourasky Medical Center?

21 A No.

22 Q Are you familiar with the University of

23 Paris?

24 A University of Paris. Paris has many

25 different universities. They're sort of numbered.


Page 193


2 Q Familiar with University of Pisa?

3 A No. I'm sure there is a University of

4 Pisa.

5 Q Okay. Are you familiar with the

6 Technion-Israel Institute of Technology?

7 A Yes.

8 Q The Rappaport School of Medicine?

9 A Mm-hmm.

10 I can tell you one thing because I've

11 talked to Israelis about Shoenfeld, and Shoenfeld's

12 opinions are not majority opinions even in Israel.

13 Q But for better or worse, there is a

14 syndrome out there that is called

15 autoimmune/autoinflammatory syndrome induced by

16 adjuvants, and there are apparently professors at

17 universities who disagree about the syndrome. But

18 it is out there, right?

19 A There is -- Shoenfeld has postulated the

20 syndrome, yes.

21 Q And there's at least 70 professors at

22 universities around the world that are in agreement

23 with that syndrome in his book --

24 A No, absolutely not. I'll bet if you go

25 through that book and talk to them, you would find


Page 194


2 that most of them probably do not agree because all

3 of the articles in this book don't say that vaccines

4 cause autoimmunity. Some of them do.

5 Q Okay. There has been concern raised that

6 aluminum adjuvants of vaccines can cause

7 autoimmunity.

8 A There has been concerns raised, yes.

9 Q Okay. So if there's been concerns raised

10 that aluminum in vaccines can cause autoimmunity and

11 there's this medical text with which I understand

12 your opinion on, why combine the autoimmunity rate

13 in the aluminum adjuvant control with the

14 autoimmunity rate in the saline placebo? Why not

15 break those out to show them separately?

16 A Well, they did to some extent. But I

17 think the reasoning was that they wanted to be sure

18 that the reactions that were seen -- and let me

19 parenthetically say that HPV vaccine is painful.

20 And they wanted to be sure that the reactions that

21 they were seeing were not caused by the adjuvant or

22 that they were specific to the HPV antigens

23 themselves and not to the adjuvants. So I can judge

24 that's why they did that.

25 Q Well, under that logic, then they


Page 195


2 certainly should have broken out the aluminum

3 control from the saline placebo control and showed

4 them in two separate columns on page 8, correct?

5 A They probably should have, yes.

6 Q So that you could see the difference in

7 autoimmune rate between the individuals receiving

8 the aluminum and the saline placebo, correct?

9 A Yes.

10 Q Okay. In your experience, would you

11 expect 2.3 percent of the girls, of girls and women

12 in this country between the ages of nine and 26 to

13 develop a systemic autoimmune condition in a

14 six-month period?

15 A Well, that's a hard question for me to

16 answer. I am not a rheumatologist. But the, when

17 they say "autoimmune conditions," I'd have to read

18 exactly --

19 Q There's a list --

20 A -- what they mean.

21 Q If you go to page 8, they've got a long

22 list right there of the conditions. Starts with

23 arthralgia.

24 A Right. Yeah. So they have included just

25 about everything that you could consider in


Page 196


2 autoimmune disorder. And all I can say is that they

3 have, as I -- well, as I've just said, they've

4 attempted to include everything. And those are the

5 data. You know, what can I say?

6 As far as 2.3 percent autoimmune

7 disorders in six months, these are women nine

8 through 26 years of age, so they're not just girls.

9 And I don't think it's impossible that that's the

10 case, especially when you have a list of disorders

11 that is so comprehensive as this.

12 Q Okay. So 2.3 percent in six months,

13 4.6 percent in a year, in ten years half the women

14 in this country would have autoimmunity. In your

15 experience, would that be accurate?

16 A Well, again, I am not a rheumatologist, so

17 I cannot answer that question specifically. All

18 that I can say is that they attempted to do a

19 comprehensive study of autoimmune phenomena or

20 putative autoimmune phenomena in this study, and

21 that's what they found.

22 Q What, do you know the percentage of girls

23 in the saline placebo group that developed a

24 systemic autoimmune condition during this clinical

25 trial versus the AAH control --


Page 197


2 A No, I --

3 Q -- AAHS?

4 A No, I did not, without going back to the

5 original study.



8 BY MR. SIRI:


10 been marked as Plaintiff's Exhibit 17. This is the

11 clinical trial data for the saline placebo control

12 group in the GARDASIL trial.

13 You can go to page 2, Dr. Plotkin.

14 You can see that the number of vaccinated in the

15 placebo is 596, right? Or you can see at the top on

16 the first page. I'm sorry.

17 On the first page, Dr. Plotkin, it

18 says: A study of GARDASIL in preadolescents and

19 adolescents, correct?

20 A Yeah.

21 Q Page 2, you can see this. It has the 596

22 saline placebo recipients. Can you please turn to

23 the serious adverse event section, which is one,

24 two, three, four, five, six, seven, the seventh

25 page. They don't print with page numbers,


Page 198


2 unfortunately.

3 A Serious adverse events.

4 Q Okay. Now, if you go to the next page,

5 one right after that, take a look at that. You can

6 see that the second column is the placebo, the

7 results of the placebo group, correct?

8 A Mm-hmm.

9 Q Can you please take a minute and go

10 through each page and tell me if there was any value

11 that wasn't zero in terms of finding a serious

12 adverse event?

13 A No, I don't see any.

14 Q So in the saline placebo group during the

15 trial, there was not a single systemic autoimmune

16 disorder that was reported, but yet there was 218,

17 2.3 percent, or maybe more actually, in the AAH

18 control when you pull out the saline placebo group.

19 Let me ask -- go ahead, please.

20 A Again, you have to do the arithmetic. But

21 if you subtract the 600 or so from the total, you

22 can easily figure out the percentage in the aluminum

23 group.

24 Q Right. So let's do that. Let's do that.

25 So there's 900,412 in the aluminum group -- excuse


Page 199


2 me, in the total, in all of, in both groups

3 combined.

4 A Yeah.

5 Q If we pull out the saline placebo group of

6 594 from the 9,412, would that make the 2.3 percent

7 number go up or down?

8 A It would go up slightly. That would be --

9 I'd have to go back and look at the numbers. But

10 that would be reducing the total to about 8800. So

11 I guess that would be in here, right?

12 Q Go to page 8.

13 A Right.

14 Q The point is, is that if they would have

15 broken out --

16 A Two hundred over 8800, and I doubt if that

17 would show a significant difference between the

18 GARDASIL and the AAHS group.

19 Q So the GARDASIL group would 2.3, shows

20 2.3 percent?

21 A Yeah.

22 Q If we took out the saline placebo group

23 from the second column, it would show 2.3 or above,

24 around 2.3 still, correct?

25 A Maybe.


Page 200


2 Q A little higher, 2.4, 2.5?

3 A 2.5. Yeah.

4 Q 2.5. And then if we had a third column

5 that was just the saline placebo, it would show

6 0 percent?

7 A Yeah.

8 Q Wouldn't that have been a significant

9 finding to report?

10 A I don't -- you'd have to ask a

11 statistician. But I doubt the statistical

12 difference would be significant.

13 Q Doesn't it at least caution having a

14 larger saline placebo group if your concern is

15 statistics in terms of statistical power, which I

16 assume --

17 A Yeah, they might have done that, if

18 they --

19 Q But they didn't do that?

20 A Yes. I don't know what that decision was

21 based on. But if you're talking about implication

22 of aluminum, at this point there's really no reason

23 to suspect that aluminum by itself can cause

24 autoimmune disease.

25 Q Here's the clinical, prelicensure clinical


Page 201


2 study in which 2.3 percent of participants in the

3 GARDASIL group and in the control group had a

4 systemic autoimmune disorder, and it was deemed safe

5 because they were around the same rate, right?

6 A Yes.

7 Q But the saline placebo group that didn't

8 get the aluminum adjuvant had a 0 percent, right?

9 A A small group, yes.

10 Q Of 594?

11 A Yeah.

12 Q And so the vaccine apparently -- if you

13 turn back, Dr. Plotkin, to page 4, please of the

14 GARDASIL insert.

15 Are you there?

16 A Yeah.

17 Q Do you see they break out GARDASIL in one

18 column, those who received AAHS control in another,

19 and those that had saline placebo in a third column?

20 A Right.

21 Q And that's with only 320 participants in

22 the saline group in table one, correct?

23 A Yes.

24 Q Okay. And in table two they break it out

25 as well, correct, the saline group from AAHS control


Page 202


2 group?

3 A Yes.

4 Q If you turn to page 5, they, again, break

5 out the GARDASIL/AAH control and saline placebo

6 groups in tables three and four, correct?

7 A Yes.

8 Q But they chose to conveniently combine it

9 when it came to systemic autoimmune disorders,

10 right?

11 A Well, in the case of the page 4 and 5,

12 they were looking at local reactions. And, of

13 course, aluminum does give local reactions.

14 On page 8, whether we're looking at

15 systemic autoimmunity, I guess they believed that

16 aluminum in itself is reasonable control and would

17 not cause autoimmunity.

18 Q So going into the study, they just assumed

19 aluminum wouldn't cause autoimmunity and so that's

20 how they proceed in designing it. I got it. All

21 right.



24 BY MR. SIRI:



Page 203



3 This is the manufacturer insert for a

4 drug called Enbrel, correct?

5 A Mm-hmm.

6 Q What is Enbrel a drug for?

7 A Well, it's essentially an

8 immunosuppressive, and I think it's used a lot for

9 autoimmune diseases and cancers.

10 Q This is a drug given to sick people, not

11 healthy people, correct?

12 A Right.

13 Q Unlike vaccines which are typically given

14 to healthy children and babies, right?

15 A Right.

16 Q If you turn to page 10, Dr. Plotkin, all

17 the way to the bottom, the 6.1, Section 6.1,

18 clinical studies experience.

19 A Mm-hmm.

20 Q The very first line under 6.1 says: The

21 data described below reflects exposure to Enbrel in

22 2,219 adult patients with RA followed for up to

23 80 months.

24 A Mm-hmm.

25 Q So that in studying this drug given to six


Page 204


2 people, they reviewed safety for up to six and a

3 half years --

4 A Mm-hmm.

5 Q -- correct?

6 And they also use --

7 (Reporter clarification.)

8 BY MR. SIRI:

9 Q Was that yes?

10 A Yes.

11 Q And there was, and the placebo group here

12 was, in this study was a saline placebo for all

13 controls, correct?

14 A Yes. So what is your point?

15 Q I think the point speaks for itself,

16 Dr. Plotkin.

17 A It doesn't because Enbrel is given over

18 long periods of time. And one has to, since its

19 immunosuppressive, one has to look for things that

20 may happen because of immunosuppression. Vaccines

21 are given at particular times and are generally not

22 continuously given over long periods of time.

23 But because, aside from that, you're

24 basing this on the package circulars, not on the

25 combined experience with the vaccines that in many


Page 205


2 cases has taken place over 50 or 60 years.

3 Q I'm basing this -- Dr. Plotkin, I'm not

4 basing anything on anything. I'm just asking you

5 questions. And my questions are geared towards

6 being able for my client to be able to pick up what

7 is supposed to be a document that includes the

8 clinical trial experience of the particular biologic

9 or drug and understand what the adverse events rate

10 was for that product.

11 That's all I'm trying to ask you

12 questions about, to understand. That's it. And in

13 terms of your, what you've just said about Enbrel,

14 let's just -- we'll just have one quick vaccine, and

15 then you've really got to move on because I've got a

16 little more material to cover. DTaP vaccine is

17 given at two months of age, correct?

18 A Yes.

19 Q And at four months of age?

20 A Yes.

21 Q And at six months of age?

22 A Yes.

23 Q Eighteen months?

24 A Yes.

25 Q At three to four years of age?


Page 206


2 A Yes.

3 Q And then again at 11 years of age?

4 A Yes.

5 Q In a slightly DTaP version?

6 A Mm-hmm.

7 Q So here you have just one vaccine -- put

8 aside the other one -- that is given over an

9 extended period of time. But yet as we saw, as the

10 manufacturer inserts will show, there is no clinical

11 trial that I'm aware of. And I'm happy for you to

12 show me or produce one that actually does what the

13 study in Enbrel does, which is has a saline placebo

14 control group and reviews safety over anything more

15 than, you know, typically a few days or 30-day

16 period.

17 A I dispute that. I think it is almost

18 certain, or is certain in my mind, that they observe

19 the patients over a longer period of time, but that

20 they looked specifically for acute reactions during

21 the first few days after immunization.

22 And, also, I add to that, and I

23 insist on repeating that one has to look at the

24 total experience with a drug or a vaccine over a

25 period of time, not simply what is in the FDA


Page 207


2 package circular.

3 Q So are you saying that the, instead of

4 relying on clinical data, saline, inert,

5 placebo-controlled studies, we should just rely on

6 the experience -- well, isn't it true that there's a

7 lot of people out there -- in fact, you've said a

8 lot of, used a lot of adjectives for them today so

9 far -- who are out there and say that their

10 experience is that vaccines have caused all kinds of

11 serious adverse reactions? Isn't that precisely

12 what is on Section 6.2 of each of those inserts?

13 If your approach is used, why are

14 they not given equal weight, I mean, if that's the

15 way we're going to do science? I'm asking for the

16 clinical data.

17 A Science depends on a body of work. It

18 does not depend on any single studies. It depends

19 on repetition, on data that confirm other data. And

20 so you cannot take any single study and rely on that

21 and say that is the truth. The truth comes out of

22 repetition and experience.

23 Q So is your point just to trust you versus

24 actually have the actual data to support --

25 A No. It's the accumulation of data.


Page 208


2 Q And you can provide data to support

3 everything you're saying here today, correct?

4 A Everything that I'm saying is in this

5 book.

6 Q You wrote that book?

7 A Sorry?

8 Q You're the editor of that book, correct?

9 A Yes.

10 Q It's called Plotkin's Vaccines?

11 A Yes.

12 Q Dr. Plotkin, what is thrombocytopenia?

13 A Decreased platelets.

14 Q Can it be caused by an autoimmune

15 reaction? Isn't that what it's known to be caused

16 by, the body attacking its own platelets?

17 A That's one of the reasons, yes.

18 Q Can the MMR vaccine cause

19 thrombocytopenia?

20 A Yes.

21 Q What is brachial neuritis?

22 A Brachial neuritis is basically a reaction

23 to a local injection where you have pain in the arm.

24 Q I'm going to read you a definition of

25 brachial neuritis from Johns Hopkins Medicine, and


Page 209


2 you can tell me if you agree or disagree with it.

3 Quote: Brachial neuritis is a form

4 of peripheral neuropathy that affects the chest,

5 shoulder, arm, and hand. Peripheral neuropathy is a

6 disease characterized by pain or loss of function in

7 the nerves that carry signals to and from the brain

8 and spinal cord, the central nervous system, to

9 other parts of the body, end quote.

10 A Yes.

11 Q Can DTaP or Tdap cause brachial neuritis?

12 A If it's administered in the incorrect way,

13 yes.

14 Q Can the MMR cause febrile seizures?

15 A Yes.

16 Q Can the flu shot cause Guillain-Barre

17 syndrome?

18 A Uncertain, but possible.

19 Q Can the DTaP or Tdap cause Guillain-Barre

20 syndrome?

21 A Not that I'm aware of.

22 Q Hepatitis B cause Guillain-Barre syndrome?

23 A Again, I don't think the evidence supports

24 that. Guillain-Barre syndrome is a not-uncommon

25 event, particularly in adults.


Page 210


2 Q After vaccination, is that what you mean?

3 A No. I mean in general.

4 Q In general. Okay.

5 Can the hepatitis B vaccine cause

6 encephalitis?

7 A No, I would say definitely not.

8 Q Can the MMR vaccine cause acute or chronic

9 arthritis?

10 A It can cause, in adults, it can cause

11 acute arthralgia, I would say, pains in the joints.

12 But that does not seem to be a permanent phenomenon.

13 And it's unusual in children.

14 Q So yes for the acute in adults, but

15 otherwise uncertain?

16 A In children, it must be quite rare, if it

17 occurs at all. But it does occur in adult women.

18 Q Can the flu shot DTaP or hep B cause

19 transverse myelitis?

20 A I would say that's unlikely. You said

21 influenza. What did you say, hepatitis B?

22 Q Or DTaP.

23 A Or DTaP. I think that's the most

24 unlikely.

25 Q More likely that it would be the flu shot


Page 211


2 or hep B?

3 A Well, it's difficult with influenza

4 because it is such a widely used vaccine. But I

5 don't see any medical reason why any one of those

6 vaccines should cause transverse myelitis.

7 Q But it has been reported?

8 A It has been reported. Influenza, I

9 suppose, may be, but I'm not aware of any proof.

10 Q Are you aware that -- okay.

11 Can hepatitis B or the flu shot cause

12 fibromyalgia?

13 A Fibromyalgia, that's such a vague

14 syndrome. It's, again, difficult to know. But

15 influenza is, there's some differences between

16 influenza vaccine and other vaccines. But with

17 hepatitis B, I don't see any reason why it should

18 cause fibromyalgia.

19 Q So no on the hep B and maybe on the flu?

20 A Yeah, I guess it boils down to that.

21 Q Can DTaP or Tdap cause acute disseminated

22 encephalomyelitis?

23 A I would say no.

24 Q Can the hepatitis A vaccine cause

25 autoimmune hepatitis?


Page 212


2 A Oh, dear. No.

3 Q Can hepatitis B cause lupus?

4 A I see no reason why it could.

5 Q That's a no?

6 A No.

7 Q Can influenza cause lupus, influenza

8 vaccine?

9 A I can see no mechanistic reason why it

10 would. So I would say no.

11 Q Can hepatitis B vaccine cause rheumatoid

12 arthritis?

13 A There have been studies along those lines,

14 and I would say that they're unconvincing as far as

15 the vaccine causing rheumatoid arthritis. The

16 difficulty is that rheumatoid arthritis is a common

17 disease. And it, of course, occurs frequently in

18 adults. So it's very difficult to know whether some

19 precipitating event could have caused it.

20 But at this point, I would say no.

21 Q Vaccines are also commonly given to most

22 people in the country, correct?

23 A They're often given, yes.

24 Q So determining causality really requires a

25 double-blind, placebo-controlled study, correct?


Page 213


2 A It does if you want to be certain or at

3 least a statistically strong relationship.

4 Q What do you mean by "statistically strong

5 relationship"?

6 A I mean a situation where you have a

7 comparative group and you can say that compared to

8 the comparative group, that the association you're

9 looking at is statistically different than the

10 control group.

11 Q And from that you believe you can

12 determine causation?

13 A Well, you can determine association. Then

14 you have to look and see whether there is some kind

15 of biological explanation.

16 Q Isn't it difficult to determine

17 association -- isn't it difficult to determine an

18 association when it comes to vaccines and an alleged

19 injury because everybody's, for the most part, gets

20 vaccinated?

21 A That is true. That is precisely why there

22 are so many false associations between vaccines and

23 disease.

24 Q Isn't it also the reason, then, that

25 careful preclinical studies using an inert placebo


Page 214


2 should be conducted before licensure?

3 A It would be ideal to do so. But one would

4 also have to, would have to be very large studies

5 and covering different age groups. And by and

6 large, those data come out much later after

7 experience with the vaccine used in thousands or

8 millions of people.

9 Q Well, that, of course, presumes that the,

10 that the adverse events are, long-term adverse

11 events are rare, doesn't it?

12 A Yes.

13 Q Do you know whether Faith is susceptible

14 to any -- strike that.

15 There's a lot of conditions, so I'm

16 going to try this a little bit of a different way so

17 we can get through this a bit quicker. Is Faith

18 susceptible to suffer any of the conditions we have

19 reviewed thus far?

20 A You mean the infectious diseases or the

21 noninfectious diseases?

22 Q I'm talking about the adverse event -- I'm

23 talking about the conditions that we just reviewed

24 starting with thrombocytopenia and ending with

25 rheumatoid arthritis.


Page 215


2 A I know nothing about the child and,

3 therefore, am unable to answer.

4 Q Do you know whether Faith has a genetic

5 variant that renders her predisposed to suffer any

6 of these conditions from vaccinations?

7 A I do not.

8 Q Do you know whether Faith has a genetic

9 variance in her microbiome DNA that renders her

10 predisposed to suffer any of the conditions we

11 reviewed?

12 A I am not aware of that.

13 Q Do you know whether Faith has any

14 environmental exposure that would render her

15 predisposed to suffer any of the conditions that

16 we've just reviewed?

17 A No.

18 Q In 1991 the IOM issued a report regarding

19 vaccine safety. Are you familiar -- correct?

20 A Yes.

21 Q Are you familiar with that report?

22 A Yes.

23 Q That report looked at 22 serious injuries

24 associated with DTaP vaccines and rubella vaccines,

25 correct?


Page 216


2 A Mm-hmm.

3 Q Did you provide information to the -- was

4 that a yes?

5 A Yes.

6 Q Did you provide information to the IOM

7 committee conducting this review?

8 A I believe I sent them papers. I was not

9 involved with the committee in any direct way.

10 Q Are you aware of whether they thanked you

11 in the introduction --

12 A They may have. I mean, I obviously was a

13 source of information about rubella vaccine, for

14 example.

15 Q The IOM searched for evidence regarding

16 whether DPT can cause autism, correct?

17 A Yes.

18 Q And they could not find any evidence that

19 would help them to make any determination one way or

20 another with regard to whether DPT caused autism,

21 correct?

22 A Well, if you mean that they used their

23 statement of not having enough information to make a

24 decision, probably yes.

25 Q Do you recall that they had five


Page 217


2 categories of conclusions, Dr. Plotkin, in that

3 report?

4 A Yeah, something like that they had, yeah.

5 Q The first category -- strike that.

6 Do you recall that the first category

7 was no evidence bearing on a causal relation?

8 A I don't recall specifically, but I believe

9 you're correct.

10 Q I'll give you a copy. Let's get you a

11 copy.



14 BY MR. SIRI:

15 Q I'm going to hand you, Dr. Plotkin, what's

16 being marked as Exhibit 19. Dr. Plotkin, the title

17 of this is "The Adverse Effects of Pertussis and

18 Rubella Vaccines," correct?

19 A Yes.

20 Q By the Institute of Medicine in 1991?

21 A Mm-hmm.

22 Q Okay. So if we go to, all the way, if we

23 go to the second-to-last page, Dr. Plotkin, I

24 suspect that's what you're looking for. This is a

25 table of the summary of conclusions by adverse event


Page 218


2 for DPT and MMR, correct?

3 A Yes.

4 Q So there are five conclusion categories,

5 correct?

6 A Mm-hmm.

7 Q The first one is no evidence bearing on a

8 causal relation, correct?

9 A Mm-hmm.

10 Q And what that means, if you see the -- was

11 that a yes?

12 A Yes.

13 Q Okay. If you go to footnote C, which

14 defines what no evidence bearing on a causal

15 relation means, isn't it true that it says: No

16 category of evidence was found bearing on a judgment

17 about causation. All categories of evidence left

18 blank in table 1-1, correct?

19 A Yes.

20 Q There's only one condition for which they

21 couldn't find any evidence one way or another on

22 whether it caused, whether the vaccine causes that

23 condition, correct?

24 A Right.

25 Q And that was -- what was that condition?


Page 219


2 A Autism.

3 Q Now, the IOM reviewed whether DPT can

4 cause 17 other serious conditions. And on this

5 chart it found that evidence supported a causation

6 for four of them for DPT; reject a causation for

7 four of them; but that the evidence was insufficient

8 to determine causation for nine of them.

9 Is that correct?

10 A Yes.

11 Q As for the MMR vaccine, the IOM reviewed

12 four conditions, right?

13 A Mm-hmm.

14 Q For the first two it -- was that a yes,

15 Dr. Plotkin?

16 A Yes.

17 Q I hate to trouble you; but if you could

18 say "yes" instead of "mm-hmm," we'd speed things

19 along and I'd appreciate it.

20 For two of them, it found that the

21 evidence was insufficient to make a causation

22 determination, correct?

23 A Yes.

24 Q But for chronic arthritis, they found that

25 the evidence is consistent with the causal


Page 220


2 relationship?

3 A Yes.

4 Q That would be, there's evidence consistent

5 with a causal relationship between the MMR vaccine

6 and chronic arthritis, correct?

7 A Yes.

8 Q And it also found that the evidence

9 indicates a causal relationship between the MMR

10 vaccine and acute arthritis, correct?

11 A Yes.

12 Q Do you dispute these findings?

13 A Well, first of all, the IOM's later report

14 was not as definitive as far as chronic arthritis is

15 concerned. And the evidence for the consistency,

16 first of all, it must be stressed, we're talking

17 about adults, women, receiving the vaccine, not

18 children.

19 And the other point is that the data

20 really came from one center in British Columbia and

21 was not generally seen. As far as acute arthritis

22 is concerned, it really should be arthralgia, not

23 arthritis, because there's a difference between

24 those two things. But anyway, there's no doubt that

25 the vaccine does cause pains in the joints, but


Page 221


2 again, particularly in adult women. It is not a big

3 problem in children.

4 Q On the next page, Dr. Plotkin, where it

5 says -- of the report, under research needs, does

6 the first sentence say: In the course of its

7 review, the committee encountered many gaps in

8 limitations and knowledge bearing directly and

9 indirectly on the safety of vaccines?

10 A Yes.

11 Q And then the last says of that paragraph

12 says: Clearly, if research capacity and

13 accomplishment in these areas are not improved,

14 future reviews of vaccine safety will be similarly

15 handicapped, correct?

16 A Right. Correct.

17 Q Okay.

18 A So I think it's worth pointing out that

19 the vaccine community did respond to those

20 conclusions and that, in particular, CDC set up a

21 situation with centers like Kaiser Permanente in

22 California where they do very elaborate safety

23 studies because they have a large, large populations

24 receiving vaccines or not receiving vaccines and

25 they can do comparative studies.


Page 222


2 And in addition, WHO has set up

3 safety reviews on vaccines. And, of course, CDC has

4 a safety department, and there are funded sort of

5 safety centers throughout the country.

6 Q Okay.

7 A So it's not as if the vaccine community

8 has ignored the issue of vaccine safety.

9 Q Well, wonderful. We'll go through all of

10 that; I can assure you. I've got to take it piece

11 by piece. Okay?

12 So one step at a time. And we will

13 get to Kaiser and the various things that you just

14 talked about. We'll address all of them. I just

15 want to, hopefully we get to everything.

16 MR. SIRI: You know what? Why don't we

17 take a, just a two-minute, quick break.

18 VIDEO OPERATOR: I'm going to end the

19 disc.

20 MR. SIRI: Perfect.

21 VIDEO OPERATOR: This ends disc No. 3 of

22 the deposition of Stanley Plotkin. We are

23 going off the record. The time is 14:23.

24 (Brief recess.)



Page 223


2 disc No. 4 of the deposition of Dr. Stanley


4 14:33.

5 BY MR. SIRI:

6 Q Dr. Plotkin, you earlier said that it

7 would be ethical, you believe, to conduct a

8 randomized, double-blind, placebo-controlled study

9 of the childhood immunization schedule using adults;

10 is that correct?

11 A You can't, I suppose you could test

12 childhood schedule in adults; but it wouldn't make a

13 lot of sense, if that's what you mean. You could

14 test individual vaccines, I suppose, although the

15 adults, in all likelihood, will have been either

16 previously vaccinated or previously infected.

17 So it wouldn't be a very easy study

18 to do, but I suppose it's conceivable.

19 Q And you think, and it is something that

20 could be done to assess the -- certainly adults are

21 not children. But it would at least give a sense of

22 the safety profile of people who've on the one hand

23 gotten the childhood schedule versus those who

24 haven't. And I would think it's something that you

25 would, you know, any, that you would welcome, given


Page 224


2 that we should hopefully, I presume, show that both

3 groups will have similar rates of any, of total

4 health outcomes.

5 A Well, it's difficult to imagine how one

6 would do it. Now, for example, for hemophilus

7 influenza, disease is rare in adults, of the type B

8 anyway. And so I'm not sure what one would learn by

9 doing such a study. For hepatitis B, of course --

10 Q The adverse events, not the efficacy,

11 Dr. Plotkin.

12 A Yeah. Well, I suppose whether it would be

13 translatable from adults to children is uncertain in

14 itself. So I don't think it's a very practical way

15 of studying the safety of vaccines.

16 Fortunately, for hepatitis B, it's

17 indicated for adults as well as children, so that's

18 something that can be done. And papillomavirus

19 vaccine, of course, can be given to adults. So we

20 have data from that type of study.

21 But in terms of systematic studies of

22 childhood vaccines in adults, I don't think that's a

23 very feasible or useful --

24 Q If the group that receives, the adults

25 that receive the full schedule versus those that


Page 225


2 didn't had significantly higher rates of autoimmune

3 or neurological or other adverse events, you don't

4 think that could provide useful information for

5 potentially making, addressing potential safety

6 concerns and making the schedule safer?

7 A So for that you need a group of adults who

8 have never received vaccines.

9 Q Why is that?

10 A Well, what are you comparing? If you're

11 comparing those who were vaccinated as children with

12 those who weren't, so you need a group that was not

13 vaccinated.

14 Q Well, most adults today have not received

15 anywhere near the number of vaccines that children

16 are being exposed to today. So, for example,

17 Dr. Plotkin, you know, when you were a child, as an

18 example, what vaccines did you receive?

19 A Diphtheria -- well, in childhood, I think

20 it was probably only diphtheria in those days.

21 Q Okay. So if such a study were

22 constructed, would you be willing to participate?

23 A You mean as someone who did not receive --

24 Q Yeah. Would you be willing to be part of

25 a study in which you would either, you know, you


Page 226


2 would be randomized; you'd either get saline

3 injections or the full childhood vaccine schedule.

4 Would you be willing to do that?

5 A Yeah. Well, that -- then you'd have to

6 have --

7 Q I'm sorry. I didn't hear the answer.

8 Would you be willing to do that?

9 A Yes. But then you'd have to have a group

10 of 80-year-olds who received all of the childhood

11 vaccines that are now given, which would be pretty

12 difficult to do. So I think this kind of study

13 you're talking about is either difficult or useless

14 because you don't have the right groups to compare.

15 You could do it, perhaps, in

16 20-year-olds, if you could find 20-year-olds who

17 haven't been vaccinated.

18 Q Well, if it was, if they did age controls

19 and so they had a range of ages, including 80- and

20 20-year-olds, would you be willing to participate?

21 A Oh, I'd be willing to participate in any

22 reasonable study.

23 Q Okay. Great.

24 A But I don't think it would be very useful.

25 Q In 1994, the IOM issued another report


Page 227


2 regarding vaccine safety. Are you familiar with

3 that report?

4 A '94?

5 Q Yeah.

6 A The last one was in the 2000, as I recall.

7 Q 2011 was the last one.

8 A Okay. Well, there was a large one in

9 about 2000 as well. Anyway, so...

10 Q 1994, let me give you...



13 BY MR. SIRI:

14 Q Handing you, Dr. Plotkin, what's been

15 marked as Plaintiff's Exhibit 20. The title of this

16 report is "Adverse Events Associated with Childhood

17 Vaccines," correct?

18 A Yes.

19 Q This is also by the Institute of Medicine.

20 This is also, in this report the IOM looked at 54

21 serious injuries associated with a number of

22 different vaccines, correct?

23 A Yes.

24 Q Okay. Did you provide information to the

25 IOM committee conducting this review?


Page 228


2 A I don't recall doing that.

3 Q Do you see on, under the acknowledgments

4 on the second page, your name is in the middle

5 there, Stanley Plotkin, Pasteur, Merieux -- I can't

6 pronounce.

7 A Merieux.

8 Q Yeah. I don't speak French. I apologize.

9 Can you pronounce that?

10 A Merieux.

11 Q That's M-E-R-I-E-U-X, C-O-N-N-A-U-G-H-T

12 Company.

13 Now, if you go to, out of these

14 54 pairs, the IOM found sufficient evidence to

15 support a causal relationship for 14 of them and

16 rejected a causal relationship for four of them.

17 Do you see that?

18 A Where are you referring?

19 Q So if you go, Dr. Plotkin, to the fourth,

20 fifth-to-last page, it has the causality table.

21 A Mm-hmm.

22 Q Do you see category three is: The

23 evidence favors rejection of a causal relationship?

24 A Yes.

25 Q Okay. And you see they rejected it for


Page 229


2 four of the associated adverse events, correct?

3 A Mm-hmm.

4 Q Is that a yes?

5 A Yes.

6 Q You see in category four, it says: The

7 evidence favors acceptance of a causal relation?

8 A Yes.

9 Q Okay. Do you see that there is, there are

10 five conditions listed there, including

11 Guillain-Barre, brachial neuritis, anaphylaxis.

12 Do you see that?

13 A Yes.

14 Q And on the next page for category five,

15 which is the evidence establishes a causal relation,

16 do you see that it lists one, two, three, four,

17 five, six, seven conditions, correct?

18 A Yes.

19 Q Okay. However, for the remaining

20 conditions, so they looked at 54, if we subtract out

21 the three categories we just looked at, 38 of those

22 conditions, the 38 remaining conditions, the IOM

23 couldn't make a causality determination because the

24 science hadn't been conducted yet, right?

25 A Yes.


Page 230


2 Q The IOM stated at the end of this report,

3 quote: The lack of adequate data regarding many of

4 the adverse events under study was a major concern

5 to the committee. Presentations of public meetings

6 indicated that many parents and physicians share

7 this concern.

8 Do you see the last page of the

9 report that you're holding of the excerpts? Do you

10 see that it says that on the first two lines under:

11 Need for research and surveillance?

12 A Yes.

13 Q Dr. Plotkin, in 2011, the IOM then issued

14 its, another report on vaccine safety. And this

15 time it looked at 158 of the most commonly claimed

16 serious injuries after vaccination, right?

17 A Yes.

18 Q The title of that report is Adverse

19 Effects of Vaccines: Evidence of Causality?

20 A Yes.

21 Q You're familiar with that report?

22 A Yes.

23 Q Do you know who commissioned and paid for

24 that report, by the way?

25 A Which commission?


Page 231


2 Q I'm sorry. Who commissioned and paid for

3 that report?

4 A No.

5 Q Would it be surprising to you if I told

6 you that HRSA, the agency within HHS that defends

7 against vaccine injury, claims they commissioned

8 that report?

9 A Wouldn't surprise me.

10 Q Did you provide information to the IOM

11 committee conducting this review?

12 A I don't recall specifically whether I did

13 or not. A lot of people ask for my opinions. When

14 asked, I give my opinions.


16 been marked as Exhibit 21.



19 BY MR. SIRI:

20 Q Is this the 2011 IOM report we were just

21 talking about?

22 A Yes.

23 Q Do you see there's Roman, little Roman

24 numeral seven, page little Roman numeral seven, see

25 a section entitled Reviewers?


Page 232


2 A Oh, yes. I'm on the list.

3 Q Do you see -- I'm going to the first two

4 sentences and can you tell me if that's what this

5 report says.

6 It says: This report has been

7 reviewed in draft form by individuals chosen for

8 their diverse perspective and technical expertise in

9 accordance with procedures approved by the National

10 Research Council's Report Review Committee. The

11 purpose of this independent review is to provide

12 candid and critical comments that will assist the

13 institutions in making its published report as sound

14 as possible and to ensure that the report meets

15 institutional standards for objectivity, evidence,

16 and responsiveness to the study charge.

17 Is that what it says?

18 A Yes.

19 Q And you're one of the people they gave the

20 report to to review?

21 A Yes.

22 Q And next to your name, it says:

23 University of Pennsylvania?

24 A Yes.

25 Q It doesn't disclose that at that time you


Page 233


2 were working for all four of the major vaccine

3 makers, correct?

4 A What do you mean working for them? I

5 mean, at that point I was no longer at Pasteur

6 Merieux Connaught.

7 Q In 2011, were you receiving compensation

8 or remuneration from Sanofi?

9 A I was, yes, as I've said before. I was

10 consulting for Sanofi as well as others.

11 Q Were you consulting for Merck?

12 A Yes, probably at that time, yes.

13 Q And GSK?

14 A Yes.

15 Q Okay. And as well as a whole host of

16 other for-profit companies seeking to develop

17 vaccines, correct?

18 A Yes.

19 Q But I'm just saying, I'm just saying

20 that's not mentioned here, correct?

21 A No.

22 Q So do you know how many other individuals

23 who were involved in reviewing or compiling this

24 report were receiving money from pharmaceutical

25 companies making vaccines that's not disclosed in


Page 234


2 this report?

3 A I have no knowledge of that.

4 Q You provided handwritten comments to the

5 IOM for this report?

6 A If I reviewed the report, which apparently

7 I did, I am sure I made comments. I don't know if

8 they were handwritten. Probably not since my hand

9 reading [sic] is illegible.

10 Q All right. In this report, the IOM found

11 that 14 of the 158 serious injuries most commonly

12 reported after certain vaccines were, that the

13 evidence supported a causal relationship, correct?

14 A Where is that stated?

15 Q Well, if you go to page 3 of the report,

16 it's numeral three. Let me ask you the question a

17 different way, Dr. Plotkin. If you look at that

18 chart, you can see that there's little symbols.

19 Do you see those, Dr. Plotkin?

20 A Yes.

21 Q So an I represents inadequate to accept or

22 reject a causal relationship, correct?

23 A Yes.

24 Q And an FR means favors rejection of a

25 causal relationship, correct?


Page 235


2 A Yes. Apparently, yes.

3 Q If you look through this --

4 A Oh, FA favors acceptance.

5 Q I meant -- I said FR. I'm sorry.

6 FR favors rejection.

7 A Right.

8 Q FA favors acceptance.

9 A Mm-hmm.

10 Q And CS is convincingly supports a causal

11 relationship, right?

12 A Yes.

13 Q So I think that, I think what you'll note

14 when you look through this chart is that most of the

15 conditions have an I, correct?

16 A Yes.

17 Q Any reason -- the report indicates that

18 for 135 out of the 158 reviewed, they found that it

19 could not locate sufficient evidence to make a

20 causality determination, right?

21 A Yes.

22 Q So the IOM concluded that of the 135 most

23 commonly claimed injuries from vaccination, it

24 didn't know whether or not the vaccines caused

25 that -- let me ask you something.


Page 236


2 You know, you earlier stated that,

3 you stated that hepatitis B is, doesn't cause

4 encephalitis, right?

5 A That's, that's my opinion, yes.

6 Q But the IOM, after doing its review,

7 determined it couldn't find science to support a

8 causal determination one way or another, correct?

9 A Yes. But that means that they don't have

10 evidence for the supposition.

11 Q That it either causes or doesn't cause?

12 A Right.

13 Q They don't know?

14 A They don't know because there aren't

15 enough data.

16 Q Okay. But you have --

17 A In the absence of data, my conclusion is

18 that there are no, there's no proof that causation

19 exists.

20 Q So if there's no data to show that it

21 causes or doesn't cause --

22 A Yes.

23 Q -- your supposition is that -- am I

24 understanding that correctly?

25 A Yes.


Page 237


2 Q Is that it doesn't cause it?

3 A That there's no proof that it does.

4 Q Okay. That's different than saying it

5 doesn't cause it, correct?

6 A Correct.

7 Q So when you were saying earlier when I

8 asked you at the beginning of this whether certain

9 vaccines caused certain conditions and you said, No,

10 they don't, did you just mean that, no, there's not

11 enough evidence to make a decision one way or

12 another?

13 A I mean that there's no knowledge known to

14 me that they do certain things that are, that some

15 may have alleged happen after vaccination.

16 Q Like, for example, you know, the IOM

17 reviewed whether hepatitis B can cause lupus because

18 of lots of reports or influenza can cause lupus.

19 They concluded that there's insufficient evidence

20 one way or another to make a determination. You

21 indicated --

22 A Right.

23 Q But you indicated earlier that those

24 vaccines don't cause lupus. Your testimony, you're

25 saying that you said no because you weren't aware of


Page 238


2 a mechanism by which it could cause it; is that

3 right?

4 A Yes. That's correct.

5 Q Okay. But the science really isn't

6 available to make a determination on causation yet,

7 right?

8 A The science doesn't show that there is a

9 relationship. And it is, unfortunately, to prove a

10 negative requires a lot more data than to prove a

11 positive.

12 Q If there was a -- I mean, if there was a

13 study that was, had a placebo and a control group,

14 then we could know whether or not these conditions

15 are caused by these vaccines, correct?

16 A Yes. It would have to be an enormous

17 study and would have to be randomized ideally, which

18 is unlikely to be the case since --

19 Q It needs to be enormous because you're

20 assuming these conditions are rare, correct?

21 A Correct.

22 Q Okay. And, and this study that you're

23 saying needs to be done before vaccines are

24 licensed, they do do clinical trials, we've seen,

25 right?


Page 239


2 A Yes.

3 Q And they have thousands of people

4 typically in them, correct?

5 A Yes.

6 Q Okay.

7 A And, therefore, they can study common

8 conditions. But uncommon conditions are very

9 difficult to study because they're uncommon; and,

10 therefore, one would need a very, very large study

11 and one would have to have randomization, which is,

12 of course, inherently difficult.

13 Q If you actually had a placebo-controlled

14 study, an inert, placebo-controlled study of seven,

15 eight thousand people, you could at least determine

16 that a population of that size, whether or not

17 there's detectable adverse event rate for any of

18 these conditions, correct?

19 A For some of those conditions, yes.

20 Q All right. I'm going to show you, I'd

21 like to show you an excerpt from that report. Okay?

22 Before I do that, actually, a few

23 quick, little questions. Tdap is one of the

24 vaccines on the childhood schedule, right?

25 A Yes.


Page 240


2 Q It's administered to babies during the

3 first year of life?

4 A Yes.

5 Q We already talked about this at two, four,

6 and six months, right?

7 A Yes.

8 Q Okay. Did I say Tdap or DTaP?

9 A DTaP is the one that's used --

10 Q I meant DTaP. I meant DTaP in that

11 question.

12 COURT REPORTER: I have Tdap.

13 MR. SIRI: Okay.

14 BY MR. SIRI:

15 Q Same answer if it was DTaP, correct?

16 A Yes.

17 Q So let's correct that, please.

18 Now, as for Tdap, T-d-a-p, little d,

19 little a, little p, with a capital T, that's given

20 to pregnant women, correct?

21 A Yes.

22 Q And DTaP and Tdap refer to vaccines which

23 contain diphtheria toxoid, tetanus toxoid, and

24 acellular pertussis, correct?

25 A Yes.


Page 241


2 Q What was the IOM's conclusion in 2011

3 about whether these vaccines can cause autism?

4 A I'd have to look that up, but I feel

5 confident that they do not cause autism.

6 Q You feel confident that that's what the

7 IOM concluded?

8 A I don't remember what the IOM concluded.

9 But I don't believe there's any evidence that that's

10 the case.

11 Q Is there any evidence that that's not the

12 case?

13 Why don't I show you this,

14 Dr. Plotkin.



17 BY MR. SIRI:


19 as Exhibit 22.

20 Oh, Dr. Plotkin, may I actually have

21 that back for a moment. I'm sorry.

22 Nope. I gave you the right one.

23 Here you go. Thank you.

24 This is an excerpt from the IOM's

25 report, right?


Page 242


2 A Yes.

3 Q And this is where the IOM discusses the

4 evidence with regard to whether DTaP or Tdap cause

5 autism, correct?

6 A Correct.

7 Q Okay. If you the turn to the second page,

8 can you read the causality conclusion with regard to

9 whether DTaP and Tdap cause autism?

10 A The committee did not identify literature

11 reporting clinical, diagnostic or experimental

12 evidence of autism after the administration of

13 vaccines containing diphtheria toxoid, tetanus

14 toxoid, and acellular pertussis antigens.

15 Q Dr. Plotkin, I'm sorry. Can you please

16 read -- Dr. Plotkin, can you please read the

17 causality conclusion with regard to the -- one

18 second, Dr. Plotkin. I'm sorry. The court reporter

19 has to be able to take down the full question or

20 there won't be a clear record.

21 Can you please read the causality

22 conclusion in the IOM report with regard to whether

23 DTaP and Tdap can cause autism.

24 A The evidence is inadequate to accept or

25 reject a causal relationship between diphtheria


Page 243


2 toxoid-, tetanus toxoid-, or the acellular

3 pertussis-containing vaccine in autism.

4 Q So the IOM reviewed the available evidence

5 with regard to whether Tdap or DTaP can cause

6 autism, and their conclusion was the evidence

7 doesn't exist to show whether DTaP or Tdap do or do

8 not cause autism, correct?

9 A Yes. But the point is that there were no

10 studies showing that it does cause autism except one

11 study by two well-known anti-vaccination figures,

12 Geier and Geier, who have no legitimacy whatsoever.

13 So what they're saying is that

14 there's no evidence. And the important point from

15 my point of view is that there's no positive

16 evidence to do a proper study, as we've been

17 discussing, which would disapprove it, would involve

18 the controlled administration of vaccines and

19 withholding vaccines from children who should have

20 them.

21 Q Dr. Plotkin, is there, was the IOM able to

22 identify a single study that supported your claim --

23 strike that.

24 If you take a look at that section,

25 please, was the IOM able to identify a single study


Page 244


2 supporting that DTaP or Tdap do not cause autism?

3 A No, they did not identify a study.

4 Q Okay.

5 A But the point is, and I have to repeat

6 myself, that absence of evidence does not allow you

7 to conclude that the two phenomenon are related.

8 Q You're making assumptions, Dr. Plotkin,

9 about, I think, what's built -- I understand that.

10 I mean, I only interrupt because, you know, it's

11 3:00. And I don't mind letting you give a lot of

12 discussion about things that aren't relevant, but to

13 the question --

14 A I think it's relevant in the reports

15 issued by the IOM --

16 Q Yes.

17 A -- that their conclusion about evidence

18 not being available --

19 Q Yes.

20 A -- does not allow you to conclude that the

21 phenomena, that there is a causal relationship.

22 Q I'm not sure -- I never said that. I'm

23 not sure anybody in this room said that,

24 Dr. Plotkin.

25 A Good. I like to hear that.


Page 245


2 Q But it does allow you to conclude that the

3 evidence doesn't exist to say that DTaP and Tdap do

4 not cause autism, correct?

5 A There is not evidence to say a million

6 different things --

7 Q Okay.

8 A -- but you have to prove --

9 Q Did the IOM report look at whether the MMR

10 vaccine can cause autism?

11 A I'd have to look and see.

12 (Overtalking.)

13 BY MR. SIRI:

14 Q Yes --

15 A I believe it did.

16 Q -- it did.

17 MR. SIRI: I'm sorry. He said it did.

18 THE WITNESS: I'm looking to see.

19 BY MR. SIRI:

20 Q It said it favors rejection because it did

21 find studies --

22 A Yes.

23 Q -- correct?

24 A Yes.

25 Q That's right. So studies are possible to


Page 246


2 determine whether or not a vaccine does or does not

3 cause, does not cause autism, correct?

4 A They are possible, yes.

5 Q Okay. But the study to determine whether

6 DTaP or Tdap does not cause autism has not been

7 done, right?

8 A A study that would definitively show that

9 it doesn't has not been done, but there's no

10 evidence that it does.

11 Q But since, Dr. Plotkin, we don't know

12 whether DTaP or Tdap cause autism, right, it would

13 be a bit premature to make the unequivocal, sweeping

14 statement that vaccines do not cause autism,

15 correct?

16 A In the absence of evidence, one should not

17 draw any conclusions except that there's no

18 evidence. And so I don't infer from the absence of

19 evidence about a million different things that

20 they're necessarily true.

21 One has to do studies to determine

22 whether or not a phenomenon exists, and usually

23 those studies are done because there's some

24 suspicion that, of a relationship.

25 But in, we have no suspicions, at


Page 247


2 least I don't, that autism is caused by DTaP.

3 Q Well, you may not have that suspicion, but

4 it is one of the most commonly reported conditions,

5 adverse events, which is why it was reviewed in this

6 IOM report from DTaP/Tdap, which we discussed

7 earlier.

8 So I just, I'm not saying, I'm not

9 asking you to say that vaccines do cause autism.

10 I'm not asking that at all.

11 I'm asking you, as a scientist, can

12 you make the statement that vaccines do not cause

13 autism if you don't know whether DTaP or Tdap cause

14 autism?

15 A As a scientist, I would say that I do not

16 have evidence one way or the other.

17 Q Right.

18 A As a practicing physician, I have to weigh

19 all kinds of things in making a decision about a

20 patient, whether to do something or not to do

21 something. And I make that, those decisions based

22 on the body of knowledge, even in the absence of

23 definitive information for every case. This has

24 been true for medicine ever since its inception.

25 Q I'm asking you a simple question. I'm


Page 248


2 asking you, since the science has not yet been done

3 regarding whether DTaP or Tdap cause autism, isn't

4 it true that you cannot make the sweeping statement

5 that vaccines do not cause autism?

6 A I can make the statement that there is no

7 evidence that vaccines cause autism, and,

8 therefore --

9 Q I'm not asking you that question --

10 A -- and, therefore, and, therefore --

11 Q -- Dr. Plotkin.

12 MS. NIEUSMA: (Inaudible.)

13 It's time to move on.

14 MR. SIRI: He's not answering the

15 question.

16 THE WITNESS: -- and, therefore, vaccines

17 should be given to protect against serious

18 diseases.

19 BY MR. SIRI:

20 Q Dr. Plotkin, we've already reviewed the

21 IOM report. The IOM could not find evidence that

22 DTaP or Tdap cause autism. I'm asking you, knowing

23 that, isn't it just a bit premature to make the

24 unequivocal, sweeping statement that vaccines do not

25 cause autism?


Page 249


2 A I would say it is logically true that you

3 cannot say, you cannot point to proof that it

4 doesn't cause autism. But as physicians and public

5 health specialists, one has to make decisions in the

6 absence of thousands of pieces of information that

7 one would like to have.

8 And one of them is that vaccines

9 protect against serious infectious diseases, and

10 there's no evidence that they cause autism. So,

11 therefore, I recommend vaccinations to this child

12 and every other child who does not have a

13 contraindication.

14 Q But since there's no evidence that DTaP or

15 Tdap don't cause autism, you can't yet say that

16 vaccines do not cause autism, correct?

17 MS. NIEUSMA: (Inaudible.)

18 THE WITNESS: I could not say that as a,

19 as a scientist or a logician. But I can say as

20 a physician that, no, they do not cause autism,

21 because as a physician, I have to take the

22 whole body of scientific information into

23 consideration when I make a recommendation for

24 a child.

25


Page 250


2 BY MR. SIRI:

3 Q The IOM reviewed the science. They didn't

4 find a single study that supported whether or not

5 vaccines --

6 (Discussion off the stenographic record.)

7 MS. NIEUSMA: At this point, Dr. Plotkin,

8 just wait for him to move on to the next

9 question.

10 MR. SIRI: I'm not asking the same

11 question, Counsel. Your objection is noted.

12 I'm responding to his comments, which are

13 different every time.

14 BY MR. SIRI:

15 Q So what you're saying is a physician or

16 logician, then, you couldn't say vaccines do not --

17 you could not say vaccines do not cause autism.

18 But as a pediatrician, you're saying

19 that you would say that to a parent because you want

20 to make sure they get the vaccine; is that right?

21 A You know, I can't be sure that DTaP

22 doesn't cause leprosy. That doesn't mean that stops

23 me from using DTaP vaccine.

24 Q Are people claiming that DTaP has caused

25 leprosy? Are you aware of any such complaints?


Page 251


2 A I'm not aware of any such complaints, but

3 I wouldn't be surprised to see it on the web one of

4 these days.

5 Q Okay. But people have made enough

6 complaints about DTaP, Tdap causing autism that the

7 Institute of Medicine at the commission of HHS

8 thought it was serious enough to do a scientific

9 review, correct?

10 A Yes.

11 Q Okay. They didn't review whether DTaP

12 causes leprosy, did they?

13 A No.

14 Q Okay. So, and after conducting that

15 review, they found that there was no evidence at all

16 that they could find whether DTaP or Tdap caused

17 autism. I'm just asking you a simple question,

18 which is since there's no evidence whether DTaP or

19 Tdap cause autism, isn't it a little premature to

20 say, to make the sweeping statement that vaccines do

21 not cause autism?

22 A No, I do not agree with that. Because

23 absence of evidence works both ways. There's no

24 evidence that they do, and the ideal study has not

25 been done. I agree with that. But in the absence


Page 252


2 of any reasonable evidence that they do, I continue

3 to recommend their use.

4 Q So you're willing to make a statement that

5 a vaccine does not cause a condition even in the

6 absence of any evidence?

7 A I'm willing to state that there is no

8 evidence that the vaccine causes the condition and,

9 therefore -- and there is a lot of evidence that

10 they do protect against disease. And, therefore,

11 the child should receive the vaccines.

12 I mean, there are a million things on

13 the web, including all kinds of diet advice based on

14 ridiculous information. So why should I adopt that?

15 Q Are you saying that the IOM was engaging

16 in a ridiculous review here?

17 A They were doing a scientific review, which

18 is certainly legitimate. And their conclusion that

19 there are insufficient data to draw a formal

20 conclusion, I can understand that and appreciate

21 that.

22 But that does not mean that the

23 vaccines cause autism.

24 Q You've never been asked that. The only

25 thing I've asked you is whether or not one can


Page 253


2 assert that vaccines do not cause autism, that they

3 do --

4 A Counselor, let's be, let's be real.

5 You're asking me these questions because you want me

6 to legitimize the view that vaccines cause autism,

7 and I will not do that because absence of evidence

8 is no proof whatsoever.

9 Q I think that record is very clear,

10 Dr. Plotkin. I'm not trying to legitimize anything.

11 I'm just asking you to, I'm not trying to legitimize

12 that vaccines cause autism. I think I'm very clear

13 --

14 A I'm glad to hear that.

15 Q -- we have very clearly established what

16 the IOM found. The IOM found in their estimation no

17 evidence, right?

18 A Right.

19 Q They found no evidence that vaccines do

20 cause -- excuse me -- that DTaP or Tdap cause

21 autism. Let's make that very clear, right?

22 A Right.

23 Q They found no evidence that DTaP or Tdap

24 cause autism --

25 A Yes.


Page 254


2 Q -- period.

3 They found one study which they said

4 was unreliable because it relied on VAERS data and

5 it had no control, right?

6 A Right.

7 Q Okay. But similarly, in the same vein,

8 they also didn't find any evidence that DTaP/Tdap do

9 not cause autism. Now, that doesn't mean that

10 DTaP/Tdap do cause autism, correct?

11 A Correct.

12 Q It doesn't mean that, right?

13 A Yes.

14 Q That's right. All it means is that they

15 couldn't find a study that showed, that supported

16 that it does not cause autism, right?

17 A Yes.

18 Q Until -- and that's why they reached the

19 conclusion that they did, which is they said the

20 data is insufficient, right?

21 A Mm-hmm.

22 Q I assume you -- was that a yes?

23 A Yes.

24 Q Do you agree with the IOM's conclusion

25 that the data, the evidence is insufficient to


Page 255


2 determine whether or not DTaP/Tdap cause autism?

3 A I agree with their conclusion, but that

4 doesn't mean that I don't act on other information.

5 Q Okay. Okay. I can understand that. I

6 can understand that. But you make -- I'm not, I'm

7 not saying that -- I'm not asking you to ignore any

8 benefits you believe accrued from vaccines. Okay?

9 I'm not asking you to do that at all, Dr. Plotkin.

10 I'm simply asking you as a pure

11 matter of logic. As a pure matter of logic and

12 common sense, if you don't know whether A causes

13 something, can you say A, B -- let me not use that

14 hypothetical.

15 If you don't know whether DTaP or

16 Tdap cause autism, shouldn't you wait until you do

17 know, until you have the science to support it to

18 then say that vaccines do not cause autism?

19 A Do I wait? No, I do not wait because I

20 have to take into account the health of the child.

21 Q And so for that reason, you're okay with

22 telling the parent that DTaP/Tdap does not cause

23 autism even though the science isn't there yet to

24 support that claim?

25 A Absolutely.


Page 256


2 Q Okay.

3 A I'm also willing to tell them it doesn't

4 cause leprosy.

5 Q Again, did the IOM review whether DTaP

6 caused leprosy?

7 A No.

8 Q Okay. All right. Dr. Plotkin, has there

9 ever been a study which looked at the total health

10 outcomes of children following the CDC's vaccination

11 schedule and those who are completely unvaccinated,

12 such as Faith?

13 A Not that I'm aware of. No, I don't think

14 so. But, you know, there are all kinds of studies.

15 There's a study that suggests that children who are

16 vaccinated compared to unvaccinated children have

17 lower rates of leukemia. Now, do I believe that

18 study? I find it interesting, but I would want

19 confirmation of that study before I believed it.

20 But just to point out that Peter

21 Aaby, for example, as I mentioned before, found

22 measles vaccination had a positive effect on health

23 and reduced mortality. So I think there is abundant

24 evidence that vaccines do contribute to the health

25 of children.


Page 257


2 But in answer to your question, there

3 is no study that I know of that compared the health

4 of vaccinated children with unvaccinated children.

5 Q Why has that study not been done?

6 A Probably because it is considered bad,

7 malpractice not to vaccinate a child.

8 Q So you are saying a prospective study

9 might be improper because it would leave a child

10 unvaccinated?

11 A Correct.

12 Q Okay. What about a retrospective study?

13 A That, I suppose, could be done, but it

14 wouldn't be randomized.

15 Q When I say "retrospective," that means

16 using existing data, correct?

17 A Using --

18 Q Why don't I ask you -- strike that.

19 Can you define "retrospective,"

20 please.

21 A I mean, looking at children who had been

22 vaccinated and comparing them to children who had

23 not been vaccinated.

24 Q Okay. Presumably, HMOs, insurance

25 companies would have health data on enough


Page 258


2 vaccinated and unvaccinated children to conduct such

3 a comparison, correct?

4 A Well, I don't know, because the percentage

5 of unvaccinated children fortunately is quite low.

6 So I'm not sure how easy it would be to do that

7 study. And I would suspect that many of those

8 unvaccinated children are not in registers that

9 could be used.

10 Q You're familiar with the Vaccine Safety

11 Datalink?

12 A Yes.

13 Q Are you aware that there are a few

14 thousand children that are, my -- are you aware that

15 there are reports from the government, government

16 reports that show that there are a few thousand

17 children that are, my understanding, completely

18 unvaccinated in the VSD?

19 A Oh, I don't doubt it.

20 Q Okay. Couldn't the Vaccine Safety

21 Datalink be used to conduct a retrospective

22 "vaccinated versus unvaccinated" study to look for

23 health outcomes?

24 A Well, I don't know. Theoretically,

25 perhaps, but one would have to be convinced that the


Page 259


2 children were comparable in other ways besides being

3 vaccinated or unvaccinated.

4 Q Every time you do a retrospective study,

5 you always need to control for potential cofounders

6 [sic], correct?

7 A Yes.

8 Q That's what you're talking about,

9 controlling for cofounders, right?

10 A Yes.

11 Q And, you know, if you're doing a case

12 control, properly matching cases, or if you're --

13 right? Are you saying that -- so CDC, pharma, they

14 conduct studies all the time, right?

15 A Mm-hmm.

16 Q Including studies --

17 A Yes.

18 Q Yes. Including studies that have

19 cofounders that need to be controlled for, right?

20 A Yes, they try, yes.

21 Q Vaccine studies, especially for efficacy,

22 happen all the time, correct?

23 A Yes.

24 Q So, again, if the data is there, why not

25 do a study comparing vaccinated to completely


Page 260


2 unvaccinated children to look for the total health

3 outcome so you know what the real risks are or get

4 at least a sense of what the real risks are from

5 vaccinations?

6 A Well, I can't completely answer that

7 question. I'm sure it would be a difficult study to

8 do. But I will repeat what I said earlier about

9 measles vaccination. I would just remind you again

10 that among those children who were not --

11 Q You've already said all this, Dr. Plotkin.

12 It's fine. I got it.

13 A I'll repeat it. There were three deaths

14 and 24 cases of encephalitis. And that's

15 unbearable.

16 Q I'm sorry.

17 MR. SIRI: Can you read back what

18 Dr. Plotkin just said.

19 - - -




23 "A. Well, I can't completely

24 answer that question. I'm sure

25 it would be a difficult study to


Page 261


2 do. But I will repeat what I

3 said earlier about measles

4 vaccination. I would just

5 remind you again that among

6 those children who were not --

7 "Q. You've already said all

8 this, Dr. Plotkin. I got it.

9 "A. Well, I'll repeat it.

10 Three deaths and 24 cases of

11 encephalitis. That's

12 unbearable.")

13 BY MR. SIRI:

14 Q Dr. Plotkin, who prepared the notes that

15 are in front of you?

16 A Me.

17 Q Okay. When did you prepare those?

18 A Oh, about a week ago, I guess.

19 Q During the break, our lunch break, did you

20 talk with anybody?

21 A No -- well, yes. I talked with my wife.

22 Q Anybody else?

23 A No.

24 Q Okay. So I understand that you find

25 injuries that can result from what you've called, I


Page 262


2 believe, vaccine-preventable diseases. What I'm

3 trying to do is understand the risks of vaccinating

4 and, in particular, for Faith.

5 And can you appreciate that,

6 understand -- strike that.

7 So you just think it's too difficult

8 to look at, to do a study comparing vaccinated and

9 unvaccinated children, even though the data exists

10 to do that; is that right?

11 A Well, I simply am saying that I don't know

12 how feasible it is. I've never been asked to look

13 at it before, but I do think a priori that it would

14 be difficult because those children are very likely

15 from different socioeconomic groups and different

16 racial groups.

17 And so it would be a different study

18 to do. I don't know if it's feasible or not.

19 Q So with all of the government -- so the

20 pharmaceutical industry, you said, made

21 approximately $20 billion last year in revenue from

22 vaccine sales?

23 A I think so. I don't have --

24 Q I have the financial statements. Should

25 we review them, or do you think 20 billion is about


Page 263


2 right?

3 A I think it's about right. I'm not an

4 accountant -- I don't make --

5 Q Give or take a few, give or take a billion

6 or two, would you say?

7 A I think so, yes.

8 Q Okay. So the pharmaceutical industry has

9 $20 billion in revenue, and the CDC spends hundreds

10 of millions of dollars buying vaccines every year;

11 is that right?

12 A I think so.

13 Q But yet you don't think that the resources

14 can be done to do a single solitary study comparing

15 the health outcomes of a for-profit product given to

16 almost every child in this country to assess what

17 the rate of adverse reactions are between those who

18 get all those products and those who don't?

19 A What I said is I simply don't know whether

20 such a study is feasible or not, but I think it

21 would be difficult to do because it would not be a

22 randomized study; and, therefore, the conclusions

23 might be, might be questionable. But I don't know

24 whether such a study is feasible or not.

25 Q Aren't most studies that are done that you


Page 264


2 rely upon in that book that you have in front of you

3 not randomized?

4 A Many of them are not. Many of them are.

5 Q Do you throw out the ones that are not

6 randomized?

7 A It depends on what the purpose of the

8 study is. If it's studying immune responses, it

9 doesn't necessarily have to have a control group.



12 BY MR. SIRI:


14 being marked as Exhibit, Plaintiff's Exhibit 23.

15 Dr. Plotkin, what is an ICD-9 code?

16 A Well, it's essentially a way of coding

17 diseases for, usually for remuneration purposes.

18 Q Okay. So when a doctor administers a drug

19 or a diagnosis as a patient or something similar,

20 there's a code that they would enter into the

21 system, right?

22 A Yes.

23 Q And the ICD-9 codes are published by the

24 American Medical Association, correct?

25 A Yes.


Page 265


2 Q Okay. Please take a look at the exhibit I

3 just -- the exhibit I just handed you is the 2015

4 ICD-9-CM Professional Edition for Physicians

5 codebook, correct?

6 A Yes.

7 Q Or at least the front page and one

8 excerpt, correct?

9 A Mm-hmm. Yes.

10 Q So if you go to the second page, do you

11 see there's a code, V6.407?

12 A Yes.

13 Q What is that code for?

14 A Vaccination not carried out for religious

15 reasons.

16 Q Okay. So wouldn't it be feasible, for

17 example, to compare children who have this coding

18 who are not being vaccinated with those who are

19 being vaccinated who are in similar communities,

20 have similar demographics, and otherwise avoid as

21 much as possible other potential cofounders.

22 A Well, if you could eliminate the

23 cofounders it would be feasible.

24 Q What are the cofounders, Dr. Plotkin?

25 A Well, as I said before, the cofounders


Page 266


2 include socioeconomic level, racial grouping,

3 exposure to agents. In other words, are they living

4 in a community where it's unlikely that someone

5 unvaccinated from Ethiopia is going come into the

6 community and be able to transmit diseases?

7 I mean, I'd have to sit down and

8 write up a list of possible cofounders. But there

9 would be many of them.

10 Q So when you do studies for efficacy, are

11 you able to control for all of these cofounders?

12 A Well, usually the effort is to include as

13 many different types of individuals as possible so

14 that if there is a problem with a particular group,

15 you can identify it.

16 But doing clinical studies is not

17 always easy, and that's why the conclusions from

18 clinical studies have to be seen in relation to

19 other clinical studies.

20 Q Why is it you can control for cofounders

21 in various other vaccine studies, including in

22 vaccine safety studies that are cited in your book,

23 but you believe -- are you saying you couldn't

24 control for these same cofounders in the study of

25 vaccinated versus unvaccinated population?


Page 267


2 A I am unable to draw a conclusion about

3 whether such a study is feasible. What I'm pointing

4 out is that the likelihood of there being multiple

5 cofounders is -- confounders, sorry, is very high;

6 and, therefore, it wouldn't be an easy study to do.

7 That's all I can say. I've never sat down to try to

8 figure out how to do such a study.

9 Q Well, we've got socioeconomic, which

10 probably pretty easy to control for; racial

11 grouping, pretty easy to control for; exposure to

12 agents, since it's retrospective, you'll know if

13 there's been an outbreak in the community.

14 What other cofounders do you think

15 might exist? I mean, I'd like to hear one that --

16 can you tell me a cofounder that's not easy to

17 control for?

18 A In principle, one can control for any

19 confounding problem. The issue would be just how

20 many there are and just how large a group you would

21 need for a statistical significance. See, that's

22 another issue.

23 I mean, we accept as a valid

24 conclusion something that is false five times out of

25 a hundred. And so not only do we have to try to


Page 268


2 eliminate confounders, but we also need repetition

3 of studies to be sure that the results we got in the

4 first study were not in the five studies that were

5 false --

6 Q Great.

7 A -- in their conclusion. So you would need

8 multiple studies.

9 Q Okay. And since these are retrospective,

10 they're really just running data, right?

11 A If the data are encoded, yes.

12 Q So I asked earlier, what cofounder can you

13 list that's not easy to control for? And I did not

14 hear another cofounder. Can you tell me a cofounder

15 in this proposed study that would not be easy to

16 control for?

17 A Exposure would be probably the most

18 difficult; in other words, whether a child is living

19 in a community where exposure to disease is rare or

20 absent or whether the child is living in the

21 community where there are significant possibilities

22 of exposure. I think that would probably be the

23 most difficult to account for.

24 Q When's the last case of polio in the

25 United States, wild polio?


Page 269


2 A Oh, I forget the exact year, but it's been

3 probably 20, 25 years.

4 Q 1979 sound correct to you?

5 A Yeah, could be.

6 Q So that wouldn't be an issue, correct?

7 A No. Polio would not be an issue.

8 Q Okay. How many cases of diphtheria have

9 there been in the last ten years in the United

10 States?

11 A It's very rare or absent.

12 Q Less than five, right?

13 A Yeah.

14 Q Isn't that true for most of the diseases

15 except for maybe pertussis, right?

16 A Well, pertussis, HIV, hepatitis, those are

17 diseases that are still common.

18 Q So if we excluded --

19 A The mumps. Yeah.

20 Q Go ahead. Mumps, pertussis.

21 Okay. So since this is

22 retrospective, we would know where those outbreaks

23 are, right?

24 A Yes.

25 Q Because they're very carefully tracked by


Page 270


2 the CDC, correct?

3 A Mm-hmm.

4 Q Since we know where the outbreaks are for

5 those diseases, that could be -- was that a yes?

6 A Yes.

7 Q Since we know where those outbreaks are,

8 that could be actually probably pretty easily

9 controlled for as well, correct?

10 A In principle, yes.

11 Q Okay. So can you name me a cofounder that

12 would be difficult to control for in the study?

13 A Well, at the moment I can't think of any

14 other that would be material, although I think one

15 would have to look at genetic issues and the health

16 of other members in the family and so forth.

17 But, again --

18 Q Okay.

19 A -- I am not saying that such a study is

20 impossible. I'm just pointing out that it would be

21 a very difficult study to do, and the conclusions

22 that you could draw from the study might be very

23 limited.

24 Q Well, you keep saying it's difficult. But

25 I, and your reason for that, I understand, is


Page 271


2 potential cofounders. And I'm just trying to

3 understand what those are.

4 So you've said familial history.

5 Presumably the parents would be in the same health

6 plan as the children. So you have the parents'

7 medical history, too, correct?

8 A Mm-hmm.

9 Q So that could be controlled for as well,

10 right?

11 A Yes.

12 Q You said "mm-hmm" two questions ago --

13 A Yes.

14 Q -- that was a yes?

15 Okay. So that could be easily

16 controlled for, correct?

17 A Yes.

18 Q Okay. And so can you tell me again, can

19 you tell me a cofounder that would actually be

20 difficult to control for in this study?

21 A Well, other than the ones that I've

22 mentioned and not having thought about doing such a

23 study, that's all I can say.

24 Q If you did such a study, isn't it -- are

25 you aware that advocacy groups and other people


Page 272


2 interested in this issue have been calling for this

3 exact study of comparing vaccinated and unvaccinated

4 for 30 years already?

5 A I don't spend a lot of time on the web, so

6 I can't say that I know that such a study is being

7 requested.

8 Q Okay. Well, but you do read IOM reports

9 and CDC reports?

10 A Yes.

11 Q Okay. And you never come across any IOM

12 or CDC reports in which they specifically address

13 the repeated calls for such a study?

14 A No.

15 Q Okay. Would it be surprising to you if I

16 told you those existed?

17 A That what existed?

18 Q That CDC and IOM reports in which they

19 document the calls for such a study.

20 A Well, I wouldn't be surprised, no.

21 Q Would you be surprised to know that the

22 CDC, in fact, issued an entire report regarding

23 conducting such a study and the calls for conducting

24 such a study?

25 A And they issue the -- what did you say?


Page 273


2 Q Would you be surprised to know that the

3 CDC, in fact, issued a report in response to the

4 request for the calls for such a study?

5 A I wouldn't be surprised that there's a

6 response, no.

7 Q Okay. So in looking for such a study,

8 isn't it true that there actually has been one such

9 study conducted in the past, for the first time ever

10 in the last year, correct?

11 A I am not aware of that study.



14 BY MR. SIRI:

15 Q Okay. I'm going hand you what's been

16 marked as Plaintiff's Exhibit 24. The title of the

17 study is a "Pilot Comparative Study of the Health of

18 Vaccinated and Unvaccinated 6- to 12-Year-Old United

19 States Children," correct?

20 A Yes.

21 Q And the authors of this study are

22 Professors at the Department of Epidemiology and

23 Biostatistics, School of Public Health, Jackson

24 State University, correct?

25 MS. NIEUSMA: Just a minute.


Page 274


2 THE WITNESS: That's what it says.

3 MS. NIEUSMA: Just a minute.

4 (Inaudible.)

5 MR. SIRI: Absolutely.

6 I'm sorry. Let's just wait for counsel to

7 get a copy.

8 MS. RUBY: Sorry about that.

9 MR. SIRI: I thought it had gone. Okay.

10 So --

11 MS. RUBY: Ms. Nieusma, do you have it?

12 MS. NIEUSMA: I should in just a -- yep.

13 MS. RUBY: Thank you. Sorry about that.

14 BY MR. SIRI:

15 Q Are you familiar with this pilot study,

16 Dr. Plotkin?

17 A No. I see it's been published in the

18 Journal of Translational Science, which is not one

19 of the journals I read and is probably one of those

20 multiple so-called predatory journals that we are

21 trying to deal with currently.

22 Q So is anybody in any university that

23 publishes anything that's negative about vaccines

24 predatory or -- I forgot the other adjectives you

25 used earlier today.


Page 275


2 A No, it's not, it's not that. It's that

3 there are journals now that will publish anything

4 for money.

5 Q Oh.

6 A And I get about ten of those invitations a

7 day.

8 Q So does money influence judgment?

9 A It may.

10 Q Conduct?

11 A It may.

12 Q Okay.

13 A I cannot tell until I read this study.

14 Q I understand. So, well, in this study, if

15 you look, if you take a quick look at it, you'll see

16 that it involves looking at total health outcomes

17 between vaccinated and unvaccinated homeschooled

18 children?

19 A Yes.

20 Q When you're ready, please turn to page 5.

21 Do you see the row that says:

22 Chicken pox?

23 A Yes.

24 Q Okay. So the odds ratio for the

25 unvaccinated were twice as likely -- no. I'm


Page 276


2 sorry -- four times as likely to get chicken pox,

3 right?

4 A Yes.

5 Q .26, so odds ratio of about four. The

6 kids who were unvaccinated were about four times

7 more likely to get chicken pox?

8 A Mm-hmm.

9 Q Okay. Is that a yes?

10 A Yes.

11 Q And do you see for whooping cough, the

12 unvaccinated children were three times as likely to

13 get whooping cough?

14 A Yes.

15 Q Go down to where it says: Allergic

16 rhinitis.

17 A Yes.

18 Q What is that?

19 A Well, it's essentially runny nose because

20 of allergy.

21 Q Okay. Do you see that it says that the

22 vaccinated children were 30 times as likely to have

23 allergic rhinitis?

24 A Yes, I see that number.

25 Q Do you see that it says that vaccinated


Page 277


2 children were 3.9 times likely to have allergies?

3 A Yes.

4 Q 4.2 times as likely to have ADHD?

5 A Yes.

6 Q 4.2 times likely to have autism spectrum

7 disorder?

8 A Yes.

9 Q 2.9 times as likely to have eczema?

10 A Yes.

11 Q 5.2 times as likely to have learning

12 disability?

13 A Yes.

14 Q 3.7 times as likely to have

15 neurodevelopment disorder?

16 A Yes.

17 Q And 2.4 times as likely to have any

18 chronic condition?

19 A Yes.

20 Q Wouldn't you like to see a larger-scale

21 study that refuted these claims?

22 A It would be ideal, yes. It would

23 certainly be important to repeat the study and to

24 enroll patients in a blinded fashion. I really

25 would have to read this to see exactly how they


Page 278


2 enrolled the children or the parents in this study.

3 Q Doesn't the existence of this study,

4 though, I mean -- strike that.

5 So it at least calls for further

6 similar studies, hopefully, to either confirm or

7 disapprove the findings in the study, correct?

8 A Yes. Mm-hmm. Yes, I would agree.

9 Q I'm going to show you one more study that

10 was done with the same data from this author.



13 BY MR. SIRI:


15 been marked as Plaintiff's Exhibit 25. This is

16 another study by the, this is another publication

17 using the same data, I believe, from the same group

18 of professors at the Department of Epidemiology and

19 Biostatistics School of Public Health, Jackson State

20 University, correct?

21 A Appears that way, yes.

22 Q And the title of this one is "Preterm

23 Birth Vaccination and Neurodevelopmental Disorders:

24 A Cross-Sectional Study of 6- to 12-Year-Old

25 Vaccinated and Unvaccinated Children," correct?


Page 279


2 A Yes.

3 Q I'll give you a moment to read the

4 abstract.

5 Have you ever seen this study before?

6 A No.

7 Q Okay. So just take a moment, please, and

8 read the abstract.

9 A Mm-hmm. Yes.

10 Q So in the middle of the abstract, I'm

11 going to read two sentences. And you can tell me if

12 I've read them correctly.

13 No association was found between

14 preterm birth and NDD in the absence of

15 vaccination -- strike that.

16 Actually, Dr. Plotkin, one, two,

17 three, four, five, six, seven lines down in the

18 abstract, do you see where it starts: No

19 association?

20 A Yes.

21 Q Can you start, can you read that sentence

22 and the next one?

23 A No association was found between preterm

24 birth and NDD in the absence of vaccination, but

25 vaccination was significantly associated with NDD in


Page 280


2 children born at term. Odds ratio, 2.7.

3 Is that sufficient?

4 Q And the next sentence, please, sir. Thank

5 you.

6 A However, vaccination coupled with preterm

7 birth was associated with increasing odds of NDD,

8 ranging from 5.4 compared to vaccinated, but

9 non-preterm children to 14.5 compared to children

10 who were neither preterm nor vaccinated.

11 Q What does NDD stand for?

12 A Neurodevelopmental disorders.

13 Q And in this study it was defined as

14 learning disability, attention deficit hyperactivity

15 disorder, and autism spectrum disorder, correct?

16 A Yes. But I will also point out the

17 abstract says that it was a convenient sample of 666

18 children. So clearly it was in no way a randomized

19 study.

20 Q Shouldn't we do better studies?

21 A One would have to do a better study if --

22 Q Larger samples?

23 A Larger samples and enrolling not by

24 convenience.

25 Q Right. I believe Dr. Mawson calls these


Page 281


2 pilot studies, correct? Because nobody else is

3 doing them, so he tried with limited resources, not

4 the resources of pharmaceutical companies and the

5 CDC, to conduct such a study, right?

6 A Well, that's your interpretation. I would

7 have to read the study.

8 Q Fair enough. More than fair.

9 Is it possible that his findings in

10 both of these studies could be correct?

11 A Is it possible? Yes, of course.

12 Possibility is always possible.

13 Q Hopefully and ideally, you would conduct a

14 larger or at least additional similar studies to

15 either confirm or dispute the findings in these

16 studies, correct?

17 A Ideally, yes.

18 Q Now, let me ask you a question. In terms

19 of randomization, if -- just to make sure I

20 understand the concept, if I, for example, choose to

21 vaccinate based solely on birth dates, would that be

22 randomized?

23 A Yes.

24 Q And that would be considered a randomized

25 study?


Page 282


2 A Yes.



5 BY MR. SIRI:

6 Q I'm going hand you what's been marked,

7 what is being marked as Plaintiff's Exhibit 24 --

8 26.

9 Thank you. Sorry.

10 This is the Peter Aaby study that you

11 and I were talking about earlier, correct?

12 A This is one of them.

13 Q This is the study in which Peter Aaby

14 found that children who receive DPT in the first six

15 months of life versus those who got no vaccines died

16 at ten times the rate, correct?

17 A Right.

18 Q And in this study, you earlier said that

19 your concerns with Aaby's prior studies that had

20 similar conclusions was that they weren't

21 randomized; but in this study it was randomized,

22 correct? Because it was -- strike that.

23 In this study, in this study the

24 vaccinated versus unvaccinated children were simply

25 vaccinated or unvaccinated purely by the chance of


Page 283


2 when their birthday happened to be; isn't that

3 correct?

4 A Yes. It says they were allocated by

5 birthday. I have to see.

6 Well, you know, it's not absolutely

7 clear as to how the randomization was done.

8 Apparently there were periods of time when they were

9 vaccinating and other periods when they were not

10 vaccinating.

11 Q I think that if you -- have you read this

12 study before, Dr. Plotkin?

13 A I've glanced at it, yes. I haven't read

14 it thoroughly. But the, as I said before, the, this

15 kind of study is useful. There's no doubt about

16 that. But one needs to have some sort of

17 immunological correlate to really confirm that that,

18 that the findings are real.

19 The other point is that Peter is

20 working in an African community where there is a

21 high mortality to begin with. And that's, of

22 course, because of other factors.

23 And so whether this would be true in,

24 let's say, Denmark or elsewhere is not clear. And

25 if my memory serves, attempts to show in Denmark


Page 284


2 what Peter has found in Africa have not been

3 positive.

4 Q Are you saying that there's a randomized

5 study in Denmark comparing death rates between DPT

6 and T --

7 A It was --

8 Q One second, Dr. Plotkin. Hold on. Hold

9 on a second. I'm sorry. You've got to let me

10 finish because the court reporter can't take down

11 both of us talking. Okay?

12 I'm asking is, is there a study from

13 Denmark that compared children who received DTP

14 versus children who received no vaccines at all that

15 was randomized like this study was and that compared

16 the death rate between the two groups?

17 A Well, I'd have to go back and look, but my

18 recollection is that because in Denmark everything

19 is registered and they had excellent data on

20 vaccines being given, that they did not find an

21 effect on mortality of giving DTP.

22 Regardless, my point is that

23 mortality in the developed world is relatively rare

24 in childhood; whereas, in Africa it's obviously

25 common. Let me repeat what I said about Peter


Page 285


2 Aaby's work. It's not that I discard it or think

3 that his conclusions are wrong. What I'm saying is

4 that they are observational data, and they have to

5 be confirmed by studies of the immune responses.

6 And those have been done only to a certain degree.

7 Q When you say "studies of immune response,"

8 what do you mean?

9 A I mean, whether the immunity of the child

10 is interfered with by DTP; that is, immunity to

11 other diseases.

12 And as I mentioned before, he had

13 shown that measles has a positive, measles vaccine

14 has a positive effect. And that has been confirmed

15 by showing that measles vaccination influences

16 immunity to other diseases.

17 Q So what you're saying is you don't dispute

18 his findings that at least in this African

19 country --

20 A Yes.

21 Q -- there is a ten-times-greater death rate

22 amongst those who got DPT -- TP in the first six

23 months of life versus those who got no vaccines,

24 correct?

25 A I don't dispute his findings. I would


Page 286


2 have to look further to make sure that the

3 populations that were studied were absolutely equal

4 in other respects.

5 Q Okay.

6 A But, again, I'm not one who discards

7 Peter's studies a priori.

8 Q Earlier you told me the issue was it

9 wasn't randomized, but now --

10 A That is an important issue, yes.

11 Q And it is, this one is randomized?

12 A Well, again, I just have to be sure that

13 it was randomized, that both groups were vaccinated

14 or non-vaccinated at the same time rather than

15 sequentially.

16 Q Yes. Because it was done by birthdays.

17 When people came into the clinics, right, depending

18 on their birth date, they either got the vaccine or

19 they didn't, correct?

20 Correct?

21 A Well, subject to my reading this

22 carefully, I agree that he is claiming that it's

23 randomized.

24 Q So DTaP has been used around the world for

25 what, 30, 40 years now, 50 years?


Page 287


2 A Mainly since the 1990s.

3 Q Okay. Mainly since the 1990s.

4 A So about 20 years.

5 Q And Peter Aaby has been claiming, making

6 this claim, a respected scientist whose conclusions

7 you said you take seriously, that DTP might cause

8 more deaths than people it saves --

9 A Yeah, I --

10 Q -- but -- let me just finish my question,

11 please.

12 When do you think this extra science

13 on immunology you think is necessary is going to get

14 done so we know whether or not DTP is saving more

15 children than it kills?

16 A Well, I would imagine that WHO is looking

17 into it. I don't know that for a fact. But it also

18 has to be pointed out that the vaccine that he's

19 studying is whole-cell vaccine; it is not the

20 vaccine being used in the United States.

21 Q That's right. But it is being used in

22 most third-world countries, correct?

23 A In, the vaccines being used in the United

24 States are being used in the U.S. and Europe.

25 Q The DTP --


Page 288


2 A But the DTP, the whole-cell vaccine is

3 used very largely in Latin America and Africa.

4 Q In developing countries?

5 A Yes.

6 Q Any reason that the life of a child in a

7 developing country is not equal to that in the

8 first-world country?

9 A No.

10 Q Okay.

11 A But the whole-cell vaccine is considerably

12 cheaper.



15 BY MR. SIRI:


17 being marked as Plaintiff's Exhibit 24 -- 27. This

18 is an excerpt from the 1994 IOM report, correct?

19 A Yes.

20 Q Under risk-modifying factors, the first

21 sentence there says: The committee was able to

22 identify little information pertaining to why some

23 individuals react adversely to vaccines when most do

24 not, correct?

25 A Yes. Mm-hmm.


Page 289


2 Q Okay.



5 BY MR. SIRI:

6 Q Handing you what's being marked as

7 Plaintiff's Exhibit 28. I'm going to read you an

8 excerpt from this, and I'm going to ask you a

9 question. Okay, Dr. Plotkin?

10 A Yes.

11 Q Okay. It says: Both epidemiologic and

12 mechanistic research suggests that most individuals

13 who experience an adverse reaction to vaccines have

14 a pre-existing susceptibility. These

15 predispositions can exist for a number of reasons --

16 genetic variations in human or microbiome DNA,

17 environmental exposures, behaviors, intervening

18 illness, or developmental stage, to name just a

19 few -- all of which can interact, as suggested

20 graphically in figure 3-1. Some of these adverse

21 reactions are specific to the particular vaccine,

22 while others may not be. Some of these

23 predispositions may be detectable to prior to the

24 administration of vaccines.

25 And then skipping down a little:


Page 290


2 Much work remains to be done to elucidate and

3 develop strategies to document the immunologic

4 mechanisms that lead to adverse effects in

5 individual patients.

6 Do you disagree with what the IOM

7 wrote here?

8 A Well, not in principle. If such factors

9 can be identified. So far it has been very

10 difficult to identify so-called predispositions.

11 Q Is it not because, Dr. Plotkin, the

12 science is just not being done to make those

13 identified?

14 A Some attempts have been made. There's a

15 whole literature by Dr. Poland at the Mayo Clinic on

16 such. But the things that he studied have been

17 relatively minor reactions.

18 Q Are you aware of any serious large-scale

19 studies that have been done to assess the

20 predispositions that might result in adverse

21 reaction from a vaccine?

22 A There have been some genetic studies done.

23 Q By whom?

24 A As I said, by the Mayo group in

25 particular, and also some studies done Vanderbilt.


Page 291


2 Q Who did the studies Vanderbilt?

3 A Well, James Crowe was one of the authors.

4 Q What did the studies involve?

5 A The studies involved looking at certain

6 enzymes, particularly to see if there was an

7 association with -- let's see.

8 It was with -- I'm trying to remember

9 which vaccine it was based on. Smallpox vaccine.

10 Q Smallpox. Do people routinely get

11 smallpox vaccine anymore in America?

12 A No.

13 Q Okay. Other than the researcher at

14 Vanderbilt and the one at the Mayo Clinic that you

15 mentioned, is there anybody else that you know of

16 that is conducting any serious science to identify

17 what might, what would render a child susceptible to

18 a vaccine injury?

19 A I think the people of British Columbia are

20 doing some work.

21 Q Who is that?

22 A I can't remember the guy's name.

23 Q Is it Chris Shaw?

24 A Sorry?

25 Q Is his name Chris Shaw?


Page 292


2 A Could be. It's a whole group of people at

3 British Columbia.

4 Q They've published good science in this

5 area?

6 A Yes.

7 Q Respectable science?

8 A Yes.

9 Q And they are the ones who looked at

10 aluminum adjuvants injected into lab animals in

11 particular, correct?

12 A They have done some work with aluminum

13 adjuvants, yes.

14 Q By showing that injecting aluminum can go

15 to different parts of the animal, right?

16 A Yes.

17 Q I just want to make sure we're talking

18 about the same group of scientists --

19 A Mm-hmm.

20 Q -- at the University of British Columbia.

21 Is, so do you recall if it's Chris

22 Shaw and his group?

23 A I don't recall specifically.

24 Q Is -- okay. But it's the group at the

25 University of British Columbia that's looking in


Page 293


2 particular at aluminum adjuvants in vaccines,

3 correct, in animal models?

4 A They're looking at a lot of different

5 things, including adjuvants.

6 Q Okay. Understood. And other than the

7 group at British Columbia, Mayo Clinic, and

8 Vanderbilt, are you aware of anybody else doing such

9 science?

10 A Not that I recall, no.

11 Q Okay. If anybody would know, it'd be you,

12 right, Dr. Plotkin?

13 A Well, I don't read -- I cannot read every

14 published scientific paper.

15 Q Dr. Plotkin, I'm going to refer to the

16 various forms of aluminum adjuvant used in vaccines

17 as alum; is that okay?

18 A Yes.

19 Q Because there are different kinds,

20 correct?

21 A Yes.

22 Q Okay. What is an antigen?

23 A An antigen is usually a protein that

24 induces an immune response.

25 Q Antigens in killed vaccines, though,


Page 294


2 produce a very weak immune response, hence the need

3 to add alum to the vaccine formulation, correct?

4 A Frequently, not always.

5 Q And alum, injected alum can increase the

6 production of all kinds of cytokines, including

7 IL-1, IL-2, IL-6, IL-17, correct?

8 A Yes.

9 Q Alum can be recovered from the injection

10 site months or years after intramuscular injections,

11 correct?

12 A Well, it's, yeah, it's possible to find

13 the alum. Of course, aluminum is a frequent, shall

14 I say, present in all of us? We ingest a lot of it.

15 Q I'm talking about injected aluminum. I'm

16 asking, can it be recovered from the injection site

17 months or years after intramuscular injection?

18 A I believe it's possible, yes.

19 Q In your book that you're holding in front

20 of you, do you know if it says, quote: It is

21 established that aluminum salt can be recovered at

22 the injection site months or years after

23 intramuscular injections?

24 A Well, I'd have to look at it, but I don't

25 doubt that that's, that could be in the book, yes.


Page 295


2 Q Okay. And antigen that is absorbed by

3 alum can be taken up by macrophages and dendritic

4 cells?

5 A Yes.

6 Q Macrophages is M-A-C-R-O-P-H-A-G-E-S.

7 Macrophages are immune cells,

8 correct?

9 A Well, they are scavengers, basically.

10 Q What do they do?

11 A They take up antigens and present them to

12 other cells.

13 Q So that means that the alum as well as the

14 antigen that's bound to it are taken up by

15 macrophages and dendritic cells, correct?

16 A Yes.

17 Q Okay. Aluminum injected into the brain --

18 into the body can travel to the brain, correct?

19 A I don't know that for a fact, but wouldn't

20 be surprised.

21 Q You've never seen any studies that show

22 that aluminum injected into the body can travel to

23 the brain?

24 A I have not seen such studies, no, or not

25 read such studies.


Page 296




4 BY MR. SIRI:


6 as Plaintiff's Exhibit 29. Please take a look at

7 that.

8 In this study, do you have a problem

9 with the journal that this study was published in?

10 A No.

11 Q Is the name of the journal Vaccine?

12 A Yes.

13 Q Are you a editor in that journal?

14 A I was at one point.

15 Q And you consider that to be a prestigious

16 journal?

17 A Yes.

18 Q Okay. So in this study, conduct -- they

19 found that injecting rabbits with aluminum and then

20 dissected them, they found aluminum in the brain of

21 the rabbits, correct?

22 A Yes.

23 Q Does that change your opinion of whether

24 injecting aluminum can travel to the brain?

25 A Well, it shows experimentally that that's


Page 297


2 the case. I'd have to look at the concentrations

3 that were injected, whether they were reasonable

4 with respect to what's injected into humans.



7 BY MR. SIRI:

8 Q Here's another study. Here's another

9 study that's being marked as Plaintiff's Exhibit 30.

10 And this study involved mice. Can you please take a

11 look at it. That study is from 2009, correct?

12 A Yes.

13 MS. RUBY: Ms. Nieusma, did number 30 go

14 through for you?

15 MS. NIEUSMA: Yes. I'll let you know if I

16 don't have anything.

17 BY MR. SIRI:

18 Q And that study found that injecting

19 aluminum in mice caused motor deficits and motor

20 neuron degeneration, correct?

21 A Apparently, yes. But, again, one has to

22 compare the amounts injected with what's, what

23 amounts are injected with vaccines.

24 Q So in this study the authors note that

25 they were attempting to use dose-equivalent amounts


Page 298


2 of alum vis-a-vis the vaccination schedule. I'll

3 post that as a question, but I'll leave it to you to

4 take -- you obviously, sounds like you never read

5 this study, so you can take your time.

6 Okay. Dr. Plotkin, there's no

7 question pending about that study anymore. So let's

8 move on.

9 A Okay.

10 Q Okay? So are you familiar with a study

11 entitled "Delivery of Nanoparticles to Brain

12 Metastases of Breast Cancer Using a Cellular Trojan

13 Horse" from the Indiana University School of

14 Medicine and Rice University?

15 A No.

16 Q Are you familiar with a study from 2013

17 entitled "Slow CCL2-dependent Translocation of

18 Biopersistent Particles from Muscle to Brain"?

19 A No.

20 Q Are you familiar with the -- after this

21 deposition, I'm happy to provide you copies of all

22 these studies. You can take an opportunity to look

23 at them.

24 Are you familiar with a 2015 study

25 entitled "Highly" -- actually, you know what?


Page 299


2 Before we continue, I'm going to mark this one. The

3 study I just spoke about, I'm going to mark as

4 Plaintiff's Exhibit 32.

5 (Exhibits Plaintiff-31 and

6 Plaintiff-32 were marked for

7 identification.)

8 BY MR. SIRI:

9 Q I'm going hand this to you.

10 In this study, if you turn to page 5,

11 you can actually see pictures of the brain of

12 dissected mice injected with aluminum and pictures

13 of the aluminum in the brain. Let me know when

14 you've had an opportunity to look at that.

15 A Yes. Okay.



18 BY MR. SIRI:

19 Q Okay. That's from 2013. I'm going to

20 show you another study from 2015 being marked

21 Plaintiff's Exhibit No. 33.

22 This study involved 155 mice, again

23 injected with aluminum. And, again, you can find

24 pictures of the aluminum in the dissected mice in

25 their brains.


Page 300


2 Since we're running short on time, I

3 won't hand you all the studies on this. But having

4 had an opportunity just for the last few minutes to

5 look at a few of these studies, do you have any --

6 can aluminum injected into the body travel to the

7 brain?

8 A Well, there are experiments suggesting

9 that that is possible.

10 Q Okay.

11 A The, in particular, there's a, I know

12 there's a French group that's been, let's say,

13 working on the potential dangers of aluminum as well

14 as the British Columbia group. What we lack is

15 evidence in humans that such phenomena are causing

16 the problems that are being caused in mice, and that

17 may relate to dose issues.

18 Q Isn't that because those studies would be

19 unethical, Dr. Plotkin?

20 A No, I wouldn't say they'd be unethical. I

21 would say that looking for aluminum deposits in the

22 brains of people at autopsy, et cetera, that's

23 entirely feasible.

24 Q And so if they did autopsies of people's

25 brains and they found aluminum, then that would be a


Page 301


2 cause for concern?

3 A It could be. But one would need to

4 combine that or look at the symptoms of the patients

5 whose brains are being examined.



8 BY MR. SIRI:

9 Q I'm going to hand you one final study on

10 this. It's been marked Plaintiff's Exhibit 34.

11 This one they were very careful, my understanding

12 is, to do a number of different doses to see the

13 response.

14 A This is the French group.

15 Q That study is the French group, right,

16 that I think you were referring to earlier?

17 A Yes.

18 Q Okay. So in any event, if aluminum bound

19 to antigen does travel to the brain, Dr. Plotkin,

20 and remains there, would that cause an immune

21 activation event in the brain?

22 A I don't know whether it would or not. I'm

23 not --

24 Q Do you think it could result in

25 neurodevelopmental disorders?


Page 302


2 A Again, there's no evidence that that's the

3 case.



6 BY MR. SIRI:

7 Q I'm going to hand you what's being

8 marked -- I'm going to hand you what's marked

9 Exhibit 35. Are you familiar with -- are you

10 familiar with this book?

11 A No.

12 Q Well, then I'll give you a copy today when

13 you leave.

14 MS. RUBY: Okay. Ms. Nieusma, Exhibit 35

15 is uploading, but it might take just one

16 second.

17 MS. NIEUSMA: Okay. No problem.

18 BY MR. SIRI:

19 Q Dr. Plotkin, has an increase in IL-6 been

20 shown to induce autism-like features in lab animals?

21 A Well, IL-6 is an inflammatory cytokine.

22 And its relationship to autism, I would say, is not

23 clear. But it is an important cytokine.

24 Q Has it been shown to induce autism-like

25 features in animals when injected into animals for


Page 303


2 experimentation?

3 A I'm not aware of that, but it's quite

4 possible that that could happen if you use enough

5 IL-6.

6 Q Do you know the maximum amount -- strike

7 that.

8 Are you familiar with the study out

9 of -- are you familiar with the study entitled

10 "Inhibition of IL-6 Trans-Signaling in the Brain

11 Increases Social Ability in the BTBR Mouse Model of

12 Autism"?

13 A No.

14 Q Are you familiar with the study called

15 "Maternal Immune Activation Alters Fetal Brain

16 Development through Interleukin-6"?

17 A Vaguely, yes. Yeah.

18 Q Published in the Journal of Neuroscience?

19 A Yeah, well, I don't remember the journal.

20 Q Is that one of the journals you consider

21 respectable?

22 A Yes.

23 Q And this was out of the University of

24 California Medical Center. This is from California

25 Institute, CalTech. That institution did a number


Page 304


2 of studies regarding -- that group did a number of

3 studies relating to immune activation and

4 neurological disorder, correct?

5 A Yes.

6 Q And they found a connection between immune

7 activation and neurological historical disorders,

8 correct?

9 A Mm-hmm.

10 Q And one of the -- is that a yes?

11 A Yes.

12 Q Okay. And one of the study's findings

13 they had was that immune activation alters fetal

14 brain development through interleukin-6, correct?

15 A As I said before, IL-6 is an important

16 cytokine. I would point out in relation to immune

17 activation, that immune activation occurs as a

18 result of disease and exposure to a variety of

19 stimuli, not just vaccines.

20 Q But it can be caused by vaccines, correct?

21 A Immune activation is the objective of

22 vaccines.

23 Q Do you know the maximum amount of the

24 aluminum that is injected into a child who follows

25 the CDC schedule?


Page 305


2 A I haven't done the arithmetic, but I

3 believe it would amount to several milligrams.



6 BY MR. SIRI:

7 Q I'm going hand you what's been marked as

8 Plaintiff's Exhibit 36. Okay?

9 And before I do that, question for

10 you: The group out of the British Columbia that you

11 were -- the group out of the University of British

12 Columbia, that's out of the Department of

13 Ophthalmology and Visual Sciences?

14 A Yeah.

15 Q I'm going to hand you a letter from,

16 what's been marked as Exhibit 36, which is a letter

17 from one of the professors that runs the lab in that

18 group?

19 VIDEO OPERATOR: We have four minutes left

20 on the disc.

21 MR. SIRI: Okay.

22 BY MR. SIRI:

23 Q Have you seen this letter before?

24 A No.

25 Q Okay. This letter is from the group at


Page 306


2 the University of British Columbia you mentioned

3 before, correct?

4 A Yes.

5 Q And it's addressed to HHS, correct?

6 A Yes.

7 Q As well as NIH?

8 A Yes.

9 Q FDA and CDC, correct?

10 A Yes.

11 Q Okay. In the first paragraph, can you

12 read the first paragraph?

13 A I am writing to you in regard to aluminum

14 adjuvants in vaccines. The subject is one my

15 laboratory works on intensively and, therefore,

16 where I feel I have some expertise.

17 In particular, we have studied the

18 impact of aluminum adjuvants in animal models of

19 neurological disease, including autism spectrum

20 disorder. Our relevant studies on the general topic

21 of aluminum neurotoxicity in general and

22 specifically in regard to adjuvants are cited below.

23 Q Now, can you read the last sentence in the

24 next paragraph.

25 A In children there is growing evidence that


Page 307


2 aluminum adjuvants may disrupt developmental

3 processes in the central nervous system and,

4 therefore, contribute to ASD in susceptible

5 children.

6 Q And just the next paragraph.

7 A Despite the foregoing, the safety of

8 aluminum adjuvants in vaccines has not been properly

9 studied in humans, even though pursuant to the

10 recommended vaccine schedule published by the

11 Centers for Disease Control, a baby may be injected

12 with up to 3.675 micrograms of aluminum adjuvants by

13 six months of age.

14 Q Just the next sentence and I guess we can

15 wrap up.

16 A And in regards to the above, it is my

17 belief that the CDC's claim on its website that

18 vaccines do not cause autism is wholly unsupported.

19 So my comments are, one, that my

20 estimate was pretty much correct. Second, that,

21 unfortunately, Dr. Shaw has been associated with the

22 party that I mentioned before, Tomljenovic, who, in

23 my view, is completely untrustworthy as far as

24 scientific data are concerned.

25 So I'm concerned about Dr. Shaw being


Page 308


2 influenced by that individual. And the, I'm not

3 aware that there is evidence that aluminum disrupts

4 the developmental processes in susceptible children.

5 Q Dr. Shaw is a scientist that studies

6 aluminum regularly, correct?

7 A Yes.

8 Q Do you study aluminum regularly?

9 A No.

10 MR. SIRI: Okay. Are we done?

11 VIDEO OPERATOR: Yep. This ends tape four

12 of the deposition of Dr. Stanley Plotkin. We

13 are going off the record. The time is 16:33.

14 (Brief recess.)


16 Disc No. 5, the deposition of Dr. Stanley


18 16:43.

19 BY MR. SIRI:

20 Q Now, Dr. Plotkin, I'm handing you what has

21 been marked as Plaintiff's Exhibits 37 and 38.

22 (Exhibits Plaintiff-37 and

23 Plaintiff-38 were marked for

24 identification.)

25 BY MR. SIRI:


Page 309


2 Q Are these letters also written by

3 individuals who are very experienced in studying

4 aluminum adjuvant?

5 A Yes. Well, one of the letters --

6 Q Okay.

7 A -- is from a French group. And I would

8 point out that --

9 MS. NIEUSMA: Remember, just yes or no

10 answers, Dr. Plotkin. We're trying to get you

11 out of here -- out of there.

12 THE WITNESS: Yes.

13 BY MR. SIRI:

14 Q Okay. And is the content of these letters

15 similar to that of the letter from Chris Shaw?

16 A Yes.



19 BY MR. SIRI:


21 been marked as Plaintiff's Exhibit 39. Okay. This

22 is a study entitled "Aluminum in the Brain Tissue in

23 Autism," correct?

24 A Yes.

25 Q And it was published in the Journal of


Page 310


2 Trace Elements in Medicine and Biology, correct?

3 A Yes.

4 Q And it found, and according to its author,

5 he found what he says is some of the highest values

6 of aluminum in human tissue yet recorded in the

7 brains of these autistic children who died

8 prematurely, correct?

9 A Well, I'd have to read the paper, but

10 apparently that's the case.

11 Q And do you know that the stand-out

12 observation in this study is that the aluminum that

13 he found was in the immune cells of the brain,

14 including within immune cells traveling into the

15 brain?

16 A Yes. But they were not associated with

17 neurons.

18 Q They also found aluminum in the neurons as

19 well, Dr. Plotkin, correct?

20 A But mostly in other cells.

21 Q And immune-related cells, right,

22 immune-system-related cells?

23 A Cells that travel, yes.

24 Q What is encephalitis?

25 A Inflammation of the brain.


Page 311


2 Q What is encephalopathy?

3 A Well, it's a vague term that means

4 something's wrong with the brain.

5 Q What is encephalomyelitis?

6 A Inflammation of the brain.

7 Q Do all five of the DTaP-containing

8 vaccines sold in this country list encephalopathy

9 within seven days of a prior pertussis-containing

10 vaccine as a contraindication?

11 A In other words, if encephalitis is present

12 at the time of vaccination?

13 Q Mm-hmm.

14 A Yes, I imagine so.

15 Q No. Meaning that if there was

16 encephalopathy within seven days of a prior

17 pertussis-containing vaccination, that's a

18 contraindication to getting more pertussis

19 vaccination?

20 A Oh, yes.

21 Q Okay. And do all three of the

22 hepatitis A-containing vaccines sold in this country

23 list encephalitis or encephalopathy as a reported

24 adverse reaction in Section 6.2 of their product

25 inserts?


Page 312


2 A Well, I don't know that for sure, but I

3 imagine that it is a contraindication.

4 Q Do all three of the hepatitis B-containing

5 vaccines sold in this country list either

6 encephalitis or encephalopathy as a reported adverse

7 reaction in Section 6.2 of their product insert?

8 A Yes.

9 Q Do almost all of the flu vaccines sold in

10 this country list encephalopathy or

11 encephalomyelitis as a reported adverse reaction in

12 6.2 --

13 A Yes.

14 Q -- of their insert?

15 Does the only chicken pox vaccine

16 sold in this country list encephalitis as a reported

17 adverse reaction?

18 A Yes.

19 Q Why do you think brain swelling after

20 vaccination is being reported in all of these

21 vaccines?

22 A Anything that happens after vaccination is

23 included in contraindications. That they are

24 related causally is not necessarily the case.

25 Q What is the total quantity of antigen in


Page 313


2 most pediatric vaccines?

3 A Well, that's vary variable. I mean,

4 perhaps up to 50 milligrams. Depends entirely on

5 the vaccine.

6 Q Miniscule amount, though, very tiny?

7 A Yes.

8 Q Almost -- could you even see it with the

9 naked eye if you had it?

10 A Yeah, you could in some cases, yes.

11 Q Some cases?

12 A Mm-hmm.

13 Q But for most vaccines, it would probably

14 be very difficult?

15 A Yes.

16 Q Okay. Are there any ingredients in

17 vaccines that you're aware of that can damage

18 neurons?

19 A Not that I'm aware of, no.

20 Q Are there any vaccines, any ingredients in

21 vaccines that you're aware of that can damage human

22 cells?

23 A Oh, well, I mean, that depends on the

24 concentrations and so forth. Human cells, of

25 course, are susceptible to lots of substances. But,


Page 314


2 again, it's very much dependent on the

3 concentration.

4 Q Do any of the vaccines on the childhood

5 schedule contain monkey kidney cells?

6 A Well, the polio vaccine does.

7 Q Okay. Go ahead. I'm sorry.

8 A Go ahead. I'll stop there.

9 Q Are the monkey kidneys used in making the

10 polio vaccine removed from the monkey while the

11 animal is still alive?

12 A These days much of the polio vaccine is

13 produced in a continuous cell line of, derived from

14 monkeys rather than from monkeys, from live monkeys,

15 so to speak. So I'm pretty sure that the IPOL

16 vaccine, for example, is produced in vero cells.

17 Q Okay. And when you say "continuous cell

18 line," what do you mean by that?

19 A I mean a cell that grows continuously

20 derived from tissues that were normal tissues to

21 begin with.

22 Q I'm sorry. Say that again, Doctor.

23 A So they are cells that continue to

24 multiply, unlike cells from a, let's say, from a

25 kidney that will not continuously multiply. These


Page 315


2 are cells derived from the kidney that will continue

3 to multiply and, therefore, can be used to make

4 vaccines in.

5 Q Cells that continue to multiply unabated

6 are typically considered cancerous, right?

7 A Well, if, depends on the circumstances in

8 the cells. But it's true that cancer cells do

9 continue to replicate indefinitely. The vero cells

10 are only used at certain passage levels. They're

11 not used, you know, a thousand passages further on.

12 Q In relation to the amount of polio antigen

13 in the final polio vaccine product, how much monkey

14 kidney cell material is there in the final product?

15 Is it about the same amount? Is there more monkey

16 kidney cell? Is there less?

17 A No. I can't give you a figure offhand.

18 But the, I am pretty sure that the amount of polio

19 antigen is superior to the amount of kidney antigen.

20 Q But you're not sure?

21 A I don't recall the exact amounts.

22 Q Monkey cellular material remaining in the

23 vaccine is considered either impurities or byproduct

24 of the manufacturing process, correct?

25 A Yes.


Page 316


2 Q Do any vaccines in the childhood vaccine

3 schedule contain blood serum from calves or other

4 bovines?

5 A Well, frequently calf serum is used to

6 make the vaccine, but calf serum is removed before

7 the vaccine is used because you don't want to

8 sensitize the vaccinee to cows.

9 Q Meaning if there was cow serum remaining

10 in the vaccine, the child could develop antibodies

11 to essentially cow --

12 A Yes.

13 Q -- cow products?

14 A Yes.

15 Q And that would be -- and they could

16 develop an allergy to it, right?

17 A If there were, yes.

18 Q If there were calf serum in the vaccines,

19 correct?

20 A Yes.

21 Q But you're saying there's no calf serum in

22 vaccines, right?

23 A It is removed, yes.




Page 317


2 BY MR. SIRI:


4 been marked as Plaintiff's Exhibit 40. What is

5 this?

6 A Vaccine Excipient & Media Summary.

7 Q And who produces this document, the CDC,

8 correct, or the FDA?

9 A I think it's the FDA.

10 Q Okay. And this lists the ingredients

11 contained in various vaccines, correct?

12 A Yes.

13 Q Can you go to Kinrix on the first page.

14 That's K-I-N-R-I-X.

15 A Yes.

16 Q DTaP-IPV.

17 Do you see in the third line down it

18 says: Calf serum?

19 A Yeah. Well, that is used to grow the

20 polio virus.

21 Q Right. And this is one of the ingredients

22 that remains in the vaccine?

23 A I do not believe so. I mean, the vaccine,

24 as I said, is made using calf serum as a nutrient,

25 but it is then --


Page 318


2 Q Removed because, otherwise, it would be

3 dangerous, you said, right?

4 A Yes. Yes.

5 Q Can you go to the top of this document.

6 You see it says -- you know what? Let me ask you a

7 few other questions, and then we'll come back to

8 this document, Dr. Plotkin. Few quick questions and

9 then we'll come back to it.

10 Do any vaccines on the childhood

11 schedule contain embryonic guinea pig cultures?

12 A Embryonic guinea pig. I don't think any

13 current vaccine is made in guinea pig cells.

14 Varicella vaccine was passaged in guinea pig cells,

15 but certainly not made in guinea pig cells.

16 Q Do you know if any vaccines contain cows'

17 milk in it or products from cow --

18 A Cows' what?

19 Q Any product derived from cows' milk, any

20 component derived from cows' milk?

21 A Oh, well, could be, casein, for example,

22 could be --

23 Q Casein --

24 A -- could be used.

25 Q Dr. Plotkin -- Dr. Plotkin, and if there


Page 319


2 was casein in the vaccine, a child could become

3 sensitized to that, correct?

4 A No, I'm not sure about that.

5 Q You're not sure anymore about that?

6 A No.

7 Q Yeah.

8 A I think there are other sensitizing things

9 in calf serum.

10 Q Dr. Plotkin, can I see that a second. Did

11 I give you the right one?

12 So earlier you said -- okay. So do

13 any vaccines contain egg protein?

14 A Oh, yes. Influenza vaccines.

15 Q And do those remain in the final product?

16 A I believe they do, yes. Not huge amounts,

17 but there are traces certainly.

18 Q Do any vaccines contain gelatin from pigs?

19 A Yes.

20 Q Do any vaccines contain gelatin from cows?

21 A Actually, I think in Muslim countries,

22 they have tried to do that. But mostly it's from

23 pig.

24 Q Do any vaccines contain recombinant GMO

25 yeast?


Page 320


2 A Recombinant GMOs. Yes, I imagine so, yes.

3 Q Are there any other animal products,

4 parts, cells, material, or any other kind that you

5 are aware of that are contained in any vaccine in

6 the pediatric schedule?

7 A Well, aside from trace amounts, no.

8 MS. NIEUSMA: Guys, unfortunately, my

9 5:00 is here, so I've got to cut this short.

10 MR. SIRI: Well, we're not, we're not

11 done. So we need to, you know, so we're going

12 to --

13 BY MR. SIRI:

14 Q Can you come back tomorrow morning,

15 Dr. Plotkin?

16 A No. Absolutely not.

17 MR. SIRI: Okay. Well, Counsel, we need

18 to, how long is your -- you need to move

19 whatever you have right now, then.

20 MS. NIEUSMA: No, I don't.

21 MR. SIRI: I'm not done with the

22 deposition.

23 MS. NIEUSMA: Then re-notice it for a

24 second day.

25 MR. SIRI: I don't -- no. The notice


Page 321


2 says: From day to day. He's under subpoena.

3 He needs to be here today. It's only, it's

4 only 5:00. And it says: From day to day. So

5 tomorrow's the next day.

6 MS. NIEUSMA: If he's not available, he's

7 not available. You guys can feel free to have

8 him held in contempt while he's in

9 Pennsylvania, but I gotta go.

10 MS. RUBY: Are you available in a half an

11 hour or something, that we could take a short

12 break?

13 MS. NIEUSMA: Yeah, I can do that.

14 MR. SIRI: Okay. So let us know when

15 you're done. Half an hour. We'll start at

16 5:30, then, or if you get done earlier.

17 THE WITNESS: Does she have to be present?

18 MR. SIRI: Do you mind if we continue

19 without you being present? Dr. Plotkin says

20 he's fine with continuing without you.

21 MS. NIEUSMA: As long as he's okay with

22 that, that's fine with me. I think he's got a

23 pretty good handle on things. So I'm not too

24 concerned.

25 MR. SIRI: Okay. Great. Then we'll


Page 322


2 continue.


4 MR. SIRI: Thank you.

5 MS. RUBY: Ms. Nieusma, if you want to

6 rejoin the conversation, obviously you can dial

7 back in.

8 MS. NIEUSMA: Yeah. I'm just going to

9 leave you guys on speaker in my office and do

10 this in the conference room and I'll be back.

11 MS. RUBY: Okay.

12 BY MR. SIRI:

13 Q Do any vaccines on the childhood vaccine

14 schedule contain MRC-5 human diploid cells?

15 A Yes.

16 Q What are these?

17 A Rubella, varicella, hepatitis A.

18 Q What are MRC-5 cells?

19 A They are human fibroblast cell strain.

20 Q And how are they created?

21 A They were created by taking fetal tissue

22 and, from a particular fetus that was aborted by

23 maternal choice. And the cells, so-called

24 fibroblast cells were cultivated from that tissue.

25 The fibroblast cells replicate for about 50 passages


Page 323


2 and then die.

3 Q So MRC-5 cells are cultured cell lines

4 from aborted fetal tissue?

5 A They're not cell lines.

6 Q What are they?

7 A They're cell strains cultivated from an

8 aborted fetus, yes.

9 Q So cell strains from an aborted fetus?

10 A Yes. Yeah. They're not immortal.

11 Q They live for five generations and then

12 they die?

13 A About 50 generations.

14 Q About 50 generations and then they die?

15 A Yes.

16 Q And then how is more MRC-5 created?

17 A Well, a seed stock is made of early

18 passage cells so that one can go back to the seed

19 stock, which is, let's say, at the, more or less the

20 eighth passage and make new cells at the 20th

21 passage and use those to make the vaccine.

22 Q Okay. So these are, these cell strains

23 are human cells?

24 A Yes.

25 Q Do any vaccines on the childhood vaccine


Page 324


2 schedule contain WI-38 human diploid lung

3 fibroblast?

4 A Well, they used to, but I don't think

5 anything is made in those cells anymore. They have

6 been replaced by MRC-5.

7 Q So you're not aware of any vaccine that

8 has in its final formulation WI-38 human diploid

9 lung fibroblasts?

10 A As I said, at one point in the past,

11 RA 27/3, for example, rubella vaccine, was grown in

12 WI-38. But the supply is insufficient, so MRC-5 is

13 now used.

14 Q And these, and WI-38 was created from an

15 aborted fetus?

16 A Yes.

17 Q They took the lung tissue from the aborted

18 fetus?

19 A Yes.

20 Q And from that they'd grown this cell line,

21 correct?

22 A Yes. Cell strain.

23 Q Cell strain.

24 Is this cell line immortal?

25 A No.


Page 325


2 Q Do any vaccines in the childhood vaccine

3 schedule contain human albumin?

4 A Oh, yes.

5 Q What is human albumin?

6 A Human albumin is part of human serum.

7 Q And what is human serum?

8 A What is human serum? Human serum is part

9 of the blood that is liquid.

10 Q Right. It's the non-red blood cell part

11 of the --

12 A Yes.

13 Q -- of the blood, right?

14 From where was it obtained?

15 A The human serum?

16 Q Yes.

17 A Well, that would be variable from donors

18 who are healthy donors. That's all I can say to

19 that.

20 Q How is it used in the manufacturing

21 process?

22 A I'm sorry?

23 Q How is it used in the manufacturing

24 process?

25 A Well, serum is used to keep cells healthy


Page 326


2 during the process of making a vaccine. So, in

3 other words, since the vaccines or some vaccines

4 have to be grown in cells, you have to keep the

5 cells in a good state.

6 Q So the cells that are used -- the virus or

7 bacteria -- the viruses used in some of the vaccines

8 are grown in this human blood component?

9 A Well, yes. I believe that the serum is

10 removed in the final product, but certainly it's

11 important to keep the cells healthy during the

12 manufacture of the vaccine.

13 Q Do you think that -- so none of it remains

14 in the final product?

15 A I don't believe so, no.

16 Q Because that could be problematic, right?

17 A Well, it could be. I mean, if the

18 individual is not, not healthy.

19 Q Right. Or if maybe some of the, you know,

20 human blood components bind to some of the aluminum

21 and develop antibodies, self-antibodies, correct?

22 A If they develop antibodies against the

23 serum component, that would not be good.

24 Q Right. What, do any vaccines contain

25 human material in them that -- I'm sorry. Strike


Page 327


2 that. Apologies.

3 Do any vaccines in the childhood

4 vaccine schedule contain recombinant human albumin?

5 A Yes.

6 Q What is recombinant human albumin,

7 A-L-B-U-M-I-N?

8 A So it's a component of human serum which

9 is useful to stabilize cells and keep them healthy,

10 and it's made by genetic engineering.

11 Q Okay. So it's genetically engineered

12 human serum basically?

13 A Part of human serum, yes.

14 Q Is that, are these genetically engineered

15 protein structures?

16 A Yes. And the idea was to eliminate any

17 possibility of a contaminant from human albumin

18 obtained from the donors. So it's made in cells,

19 using the DNA for albumin, and that way one can be

20 sure that there's no contaminant.

21 Q And, again, you pretty much want to make

22 sure that none of that remained in the final

23 product, too, right?

24 A Well, human albumin is probably not much

25 of a problem in terms of causing reactions. So --


Page 328


2 Q But in terms of it potentially binding to

3 the alum, that could be problematic, correct?

4 A Well, I don't know the answer to that

5 question.

6 Q Okay. The vaccines that contain human

7 material in them, they also contain human DNA and

8 protein, correct?

9 A They may, yes.

10 Q Isn't it true that human DNA in vaccines

11 is typically purposefully fragmented to below 500

12 base pairs in length?

13 A Yes. One doesn't, you know, I would say

14 mostly for theoretical reasons, doesn't want to put

15 DNA into, attacked DNA into vaccines. I think the

16 actual risk is zero, but that's my opinion.

17 Q Isn't it true that MMR II contains

18 approximately 150 nanograms cells substrate

19 double-strand DNA and single-strand DNA per dose

20 purposefully fragmented to approximately 215 baste

21 base pairs in length?

22 A Yeah, that's probably correct, yes.

23 Q And is it true that VARIVAX, vaccine for

24 chicken pox, is manufactured using WI-38 and

25 MRC-5 --


Page 329


2 A Yes.

3 Q -- and contains approximately two

4 micrograms of cell substrate double-strand DNA or

5 approximately 1 trillion fragments of human DNA?

6 A It may be true.

7 Q Isn't it true that the Havrix, the

8 hepatitis A vaccine, also contains millions of

9 fragments of human DNA?

10 A Likely.

11 Q Do you know whether strands of DNA below

12 500 base pairs are now known to insert themselves

13 into living cells with which they come into contact?

14 A I do not have that information, but the

15 likelihood that they would be genetically included

16 in the genome of vaccinees, in my view, is zero.

17 Q Do you have a study to support that view?

18 A I do not have a study that supports that

19 view. But it is, to me, unlikely that the DNA would

20 travel from the site of injection to the semen or

21 the ovaries.

22 Q Could it insert into itself DNA even in

23 the muscle tissue or if it gets into the blood

24 into --

25 A Theoretically. But that's not going to


Page 330


2 mean that it's going to have any impact on the

3 individual.

4 Q Are you familiar with the insertional

5 mutagenesis?

6 A Yes.

7 Q Do you have any study to show that

8 injecting millions of pieces of human DNA into

9 babies and children is safe?

10 A The only studies are all the safety

11 studies that have been done on vaccines.

12 Q And you can produce those studies, right?

13 A Well, those studies are available from the

14 manufacturers and from CDC, and I'm not aware of any

15 data showing that the inheritable characteristic was

16 transmitted by a vaccine.

17 Q So you don't, you don't personally don't

18 know of any study that shows the safety of injecting

19 human, millions pieces of human DNA into babies?

20 A Such studies are general safety studies,

21 and I haven't yet seen the vaccinee develop a new

22 genetic trait as a result of vaccination.

23 Q Is it possible it can cause cancer?

24 A Anything is possible, but there are no

25 data to support that.


Page 331


2 Q Is there data to show that it doesn't do

3 that?

4 A Yes. Observations made over millions of

5 vaccinees.

6 Q Okay. And you have the studies to show

7 that, right?

8 A The studies are easily available in terms

9 of vaccine safety studies that have been done by

10 many, many people.

11 Q Excellent. Then it should be very easy

12 for you to direct me to those and can provide

13 copies?

14 A Yes.

15 Q Wonderful.

16 A You can read the chapter on vaccine

17 safety.

18 Q Vaccines contain dead or weakened polio

19 virus, correct?

20 A IPV does, yes.

21 Q Beginning in the 1950s, polio vaccines

22 were routinely grown on nonhuman primate kidney

23 cells, correct?

24 A Correct.

25 Q Are you aware of any simian monkey


Page 332


2 viruses, meaning viruses that come from primates,

3 that contaminated polio vaccines and infected

4 individuals receiving the polio vaccine?

5 A Yes. SV40.

6 Q What does that SV40 stand for?

7 A Simian virus 40.

8 Q Was it the 40th simian virus found?

9 A Yes.

10 Q Are you aware of any other simian viruses

11 that are in any vaccine?

12 A At this stage, no.

13 Q Are you aware of any bovine virus that is

14 in any vaccine?

15 A Well, bovine virus. Nothing comes to mind

16 at the moment.

17 Q Are you aware of any virus from any animal

18 other than simian or bovine that is in any vaccine?

19 A Yes. There's a pig virus present in one

20 of the rotavirus vaccines.

21 Q What is that virus called?

22 A Circovirus.

23 Q Is there more than one type, or is there

24 only one?

25 A There's more than one type, but I think


Page 333


2 only one was recovered from the vaccine.

3 Q Which one is that?

4 A I think it was 2.

5 Q Circovirus 2.

6 A I think so.

7 Q Are you aware of any retrovirus that are

8 in any vaccine?

9 A Retroviruses? No.

10 Q Are you aware of any prions that are in

11 any vaccine?

12 A No.

13 Q Are you aware of any human viruses that

14 are in any vaccine apart from the virus for which

15 the vaccine is intended?

16 A No.

17 Q You indicated that they did find a porcine

18 circovirus type 2 in rotavirus, correct?

19 A Yes.

20 Q Was that unintentional?

21 A Yes.

22 Q When it was released to the market, they

23 didn't know that virus was in there, correct?

24 A Correct.

25 Q And when they released the polio vaccine


Page 334


2 on the market, they didn't know SV40 was in there,

3 correct?

4 A Correct.

5 Q Are you aware of how many micrograms of

6 2-phen, P-H-E-N-O-X-Y-E-T-H-A-N-O-L? How do you

7 pronounce that?

8 A 2-phenoxyethanol.

9 Q Yeah. Are you aware of how many

10 micrograms of 2-phenoxyethanol a child following the

11 childhood vaccine schedule would be injected with?

12 A No. I'd have to look that up.

13 Q Do you think it's close to around a

14 hundred micrograms?

15 A It could be, but I'd have to look it up.

16 Q Do you know safe level in terms of that

17 ingredient?

18 A I am not aware that there, that there is

19 toxicity associated with 2-phenoxyethanol. It's a

20 fairly harmless substance, as far as I'm aware.

21 Q Do you know any vaccines in the childhood

22 schedule that include ferric nitrate?

23 A Ferric nitrate? No, I don't recall that.

24 Q Are you aware of how many micrograms of

25 polysorbate 80 a child following the vaccine


Page 335


2 schedule would be injected with?

3 A I don't have the amount, no.

4 Q Now, I'm going to give you back

5 Exhibit 40, Dr. Plotkin. Take a look at that a

6 moment. You indicated that you weren't aware that

7 WI-38 was in the final vaccine product. If you

8 could turn to page 3 for MMR and MMR V.


10 Q Do you see that within the ingredient list

11 that lists WI-38 human diploid lung fibroblast?

12 A Yes, I do see that.

13 Q I believe that of the ingredients that we

14 discussed until now, the rest of them you indicated

15 you are aware are in vaccines except for -- are

16 there any ingredients we discussed until now that

17 you believe are not in vaccines?

18 A Well, I'd have to go back over all the

19 questions you asked, but I do want to say that

20 WI-38, as I said before, was the original fibroblast

21 cell line. And I think that manufacturers have

22 significantly shifted to MRC-5. But WI-38 could

23 still be used. I don't see anything wrong with

24 that.

25 Q Are there any vaccine ingredients that are


Page 336


2 not listed on the FDA's official vaccine excipient

3 and media summary table that you're aware of?

4 A I don't see how I can really answer that

5 question without reading the whole thing. But I

6 imagine that it's a complete list.

7 Q Okay. Isn't it true that an adjuvant will

8 bind not only to the target antigen but also to the

9 impurities and byproduct of the manufacturing

10 process?

11 A Probably, yes.

12 Q And those impurities and byproducts are

13 all listed in what has been marked as Exhibit

14 No. 40, correct?

15 A Yes.

16 Q Okay. Once the impurities or byproducts

17 are bound to the aluminum, the body may also develop

18 antibodies to these impurities and byproducts,

19 correct?

20 A "May" is the operative word, but not

21 necessarily.

22 Q The entire purpose of the aluminum binding

23 to a protein structure, be it an antigen or some

24 other protein structure, is to cause an immune

25 response that would develop antibodies, correct?


Page 337


2 A Yes. But the protein has to be of the

3 right size and presentation in order to induce an

4 immune response. And that will not always be the

5 case if the protein is small or is something not

6 recognize by the human immune system.

7 Q Do you know whether the protein structure

8 for any of the ingredients on Exhibit 40 are not the

9 right size to bind to alum?

10 A Well, I think it's unlikely. The

11 monosodium glutamate, for example, will cause an

12 immune response. I have to look through the whole

13 thing. Amino acids probably are unlikely to induce

14 an immune response.

15 Q Anything else?

16 A You want me to read this whole thing?

17 Q Oh, no. I'm just asking, in terms of just

18 the stuff that's got protein structures in it.

19 A Well, things like calf serum, if they were

20 present, would, would possibly induce an immune

21 response. But the things on this list, the vast

22 majority of them are unlikely to do so.

23 Q Because they're not protein structures?

24 A They're not proteins or they're very

25 small.


Page 338


2 Q Okay. Other than the -- strike that.

3 How about, and we talked earlier,

4 human albumin, that would be of a big enough protein

5 structure to bind to alum, correct?

6 A It could, although the fact that it's

7 human means that individuals might well not respond

8 to -- that is, not respond to human albumin as a

9 foreign protein.

10 Q Right. Maybe not alone, right? But bound

11 to alum it might, correct?

12 A It might. But I'm not aware of evidence

13 that it does.

14 Q Are you aware of a study that looked at

15 that issue?

16 A I have not read such a study, no.

17 Q How about the human DNA, do you believe

18 that the human DNA strands can bind to the alum?

19 A No.

20 Q Why is that?

21 A I don't see any chemical reason why it

22 should.

23 Q Any reason why it shouldn't?

24 A Proving a negative is always more

25 difficult.


Page 339


2 Q Well, I'm just trying to know if you know

3 or you're just, you're not sure. That's all. I'm

4 not asking -- I'm just saying if you don't know,

5 just say you don't know. That's fine.

6 A I have no reason to believe that DNA will

7 bind to albumin.

8 Q But you don't know for sure?

9 A I have not done the experiment, no.

10 Q Okay. And do you know whether it will

11 bind to any of the cellular debris from MRC-5 or

12 WI-38?

13 A Whether human albumin would bind?

14 Q No. Whether alum would bind to MRC-5 or

15 any of the cellular debris that's in the final

16 product from MRC-5 or --

17 A Oh, I think it could, but I don't know

18 that it does.

19 Q Do you know whether alum could bind to any

20 of the cellular debris from WI-38?

21 A It might, but I don't know that for a

22 fact.

23 Q Do you know whether alum would bind to any

24 of the gelatin from pigs?

25 A I think that's unlikely.


Page 340


2 Q Why is that?

3 A I don't think that alum would bind to

4 gelatin, but I don't know that for a fact.

5 Q What about egg protein; could alum bind to

6 egg protein?

7 A Possibly.

8 Q And to casein?

9 A I suppose it's possible, but I'm not aware

10 of any evidence.

11 Q You don't know?

12 A I don't know.

13 Q Okay. In your work related to vaccines,

14 how many fetuses have been part of that work?

15 A My own personal work? Two.

16 Q Two. So in your, in all of your work

17 related to vaccines throughout your whole career,

18 you've only ever worked with two fetuses?

19 A In terms of making vaccines, yes. Yes.



22 BY MR. SIRI:

23 Q I'm going to hand you, I'm going to hand

24 you what's been marked Plaintiff's Exhibit 41.

25 Okay? Are you familiar with this article,


Page 341


2 Dr. Plotkin?

3 A Yes.

4 Q Are you listed as an author on this

5 article?

6 A Yes.

7 Q This study took place at the Wistar

8 Institute, correct?

9 A Yes.

10 Q You were at the Wistar Institute, correct?

11 A Yes.

12 Q How many fetuses were used in the study

13 described in this article?

14 A Quite a few. But my answer to the

15 previous question was what did I use to make

16 vaccines, and the answer was two.

17 Q Can you read back the question I had

18 asked.

19 COURT REPORTER: Just now or prior?

20 MR. SIRI: No. Prior.

21 - - -




25 "Q. In your work related to


Page 342


2 vaccines, how many fetuses have

3 been part of that work?

4 "A. My own personal work?

5 Two.")

6 BY MR. SIRI:

7 Q So I'm going to ask that question again.

8 In your work related to vaccines, how many fetuses

9 were involved in that work?

10 A There were only two fetuses involved in

11 making vaccines. When fetal strains of, fibroblast

12 strains were first developed, I was involved in that

13 work trying to characterize those cells; but they

14 were not used to make vaccines.

15 Q Wasn't the purpose of this study to help

16 develop a human cell line or to support the use of

17 human cell lines in the creation of vaccines?

18 A The idea was to study the cell strains

19 from fetuses to determine whether or not they could

20 be used to make vaccines.

21 Q So this was related to your work?

22 A Well, yes, in a sense --

23 Q To vaccines, correct?

24 A Yes. It was preparatory.

25 Q So this study involved 74 fetuses,


Page 343


2 correct?

3 A I don't remember exactly how many.

4 Q If you turn to page 12 of the study.

5 A Seventy-six.

6 Q Seventy-six. And these fetuses were all

7 three months or older when aborted, correct?

8 A Yes.

9 Q And these were all normally developed

10 fetuses, correct?

11 A Yes.

12 Q Okay. These included fetuses that were

13 aborted for social and psychiatric reasons, correct?

14 A Correct.

15 Q What organs did you harvest from these

16 fetuses?

17 A Well, I didn't personally harvest any, but

18 a whole range of tissues were harvested by

19 co-workers.

20 Q And these pieces were then cut up into

21 little pieces, right?

22 A Yes.

23 Q And they were cultured?

24 A Yes.

25 Q Some of the pieces of the fetuses were


Page 344


2 pituitary gland that were chopped up into pieces

3 to --

4 A Mm-hmm.

5 Q Included the lung of the fetuses?

6 A Yes.

7 Q Included the skin?

8 A Yes.

9 Q Kidney?

10 A Yes.

11 Q Spleen?

12 A Yes.

13 Q Heart?

14 A Yes.

15 Q Tongue?

16 A I don't recall, but probably yes.

17 Q So I just want to make sure I understand.

18 In your entire career -- this was just one study.

19 So I'm going to ask you again, in your entire

20 career, how many fetuses have you worked with

21 approximately?

22 A Well, I don't remember the exact number,

23 but quite a few when we were studying them

24 originally before we decided to use them to make

25 vaccines.


Page 345


2 Q Do you have any sense? I mean, this one

3 study had 76. How many other studies did you have

4 that you used aborted fetuses for?

5 A I don't remember how many.

6 Q You're aware, are you aware that the, one

7 of the objections to vaccination by the plaintiff in

8 this case is the inclusion of aborted fetal tissue

9 in the development of vaccines and the fact that

10 it's actually part of the ingredients of vaccines?

11 A Yeah, I'm aware of those objections. The

12 Catholic church has actually issued a document on

13 that which says that individuals who need the

14 vaccine should receive the vaccines, regardless of

15 the fact, and that I think it implies that I am the

16 individual who will go to hell because of the use of

17 aborted tissues, which I am glad to do.

18 Q Do you know if the mother's Catholic?

19 A I have no idea.

20 Q Okay.

21 A But she should consult her priest.

22 Q If she has a -- if she's, in fact,

23 Christian, I guess, right?

24 In any event, so we have 76 in this

25 study. Would you approximate it's been a few


Page 346


2 hundred fetuses?

3 A Oh, no, I don't think it was that many.

4 Probably not many more than in this paper.

5 And I should stipulate that we had

6 nothing to do with the cause of the abortion.

7 Q Some of these were for psychiatric

8 institutions, correct?

9 A Actually, all I can say is that the

10 fetuses that I personally worked with actually came

11 from Sweden, from a Swedish co-worker. And so I, in

12 no case, was able to determine what exactly the

13 reason for the abortion was.

14 Q I'm just asking you, some of the fetuses

15 that you did use did come from abortions from people

16 who were in psychiatric institutions, correct?

17 A I don't know that. What I'm telling you

18 is that I got them from a co-worker; and if it's

19 stated in the paper, it's true. But, otherwise, I

20 do not know.

21 Q So if it's in the paper, you don't contest

22 it, right?

23 A I don't contest it, no.

24 Q Okay. Have you ever used orphans to study

25 an experimental vaccine?


Page 347


2 A Yes.

3 Q Have you ever used the mentally

4 handicapped to study an experimental vaccine?

5 A I don't recollect ever doing studies in

6 mentally handicapped individuals. At the time in

7 the 1960s, it was not an uncommon practice.

8 Q So you're saying -- I'm not clear on your

9 answer. I'm sorry. Have you ever used mentally

10 handicapped to study an experimental vaccine?

11 A What I'm saying is I don't recall

12 specifically having done that, but that in the

13 1960s, it was not unusual to do that. And I

14 wouldn't deny that I may have done so.

15 (Discussion off the stenographic

16 record.)

17 BY MR. SIRI:

18 Q I'm going to read you a sentence from what

19 what's been previously marked as --

20 MS. RUBY: No, that wasn't.

21 BY MR. SIRI:

22 Q -- Exhibit 7.

23 MS. RUBY: That's not what got marked as

24 Exhibit 7. That got -- the task force was

25 seven.


Page 348


2 MR. SIRI: Oh.

3 MS. NIEUSMA: So this should be 42.

4 MR. SIRI: Got it. Got it. Got it.



7 BY MR. SIRI:

8 Q Well, in any event, you're not denying

9 that you, that you -- well, there's an article

10 entitled "Attenuation of RA 27/3 Rubella Virus in

11 WI-38 Human Diploid Cells." Are you familiar with

12 that article?

13 A Yes.

14 Q In that article, one of the things it says

15 is 13 -- is one of the things it says is:

16 13 seronegative mentally retarded children were

17 given RA 27/3 vaccine?

18 A Okay. Well, then that's, in that case

19 that's what I did.

20 Q Have you ever expressed that it's better

21 to perform experiments on those less likely to be

22 able to contribute to society, such as children with

23 handicap, than with children without or adults

24 without handicaps?

25 A I don't remember specifically, but it's


Page 349


2 possible. And, again, I repeat that in the 1960s,

3 that was more or less common practice. I've since

4 changed my mind. But those were, that was a long

5 time ago.

6 Q Do you remember ever writing to the editor

7 of "Ethics on Human Experimentation"?

8 A I don't remember specifically, but I may

9 well have.

10 Q We'll mark this.



13 BY MR. SIRI:


15 as Exhibit 43. Do you recognize this letter you

16 wrote to the editor?

17 A Yes.

18 Q Did you write this letter?

19 A Yes.

20 Q Is one of the things you wrote: The

21 question is whether we are to have experiments

22 performed on fully functioning adults and on

23 children who are potentially contributors to society

24 or to perform initial studies in children and adults

25 who are human in form but not in social potential?


Page 350


2 A Yes.

3 Q It may be objected that this question

4 implies a Nazi philosophy, but I do not think that

5 it is difficult to distinguish nonfunctioning

6 persons from members of ethnic, racial, economic, or

7 other groups.

8 A Mm-hmm.

9 Q Have you ever used babies of mothers in

10 prison to study an experimental vaccine?

11 A Yes.

12 Q Have you ever used individuals under

13 colonial rule to study an experimental vaccine?

14 A Yes.

15 Q Did you do so in the Belgian Congo?

16 A Yes.

17 Q Did that experiment involve almost a

18 million people?

19 A Well -- well, all right, yes.

20 Q Did you ever visit what was the Belgian

21 Congo and Ruanda-Urundi?

22 A Yes.

23 Q How many times?

24 A Once.

25 MS. RUBY: Spell it.


Page 351


2 MR. SIRI: R-U-A-N-D-A, dash, U-R-U-N-D-I.

3 BY MR. SIRI:

4 Q When was that visit?

5 A 1959.

6 Q And how long were you there?

7 A Oh, couple of months.

8 Q Two months?

9 A I think so, yes.

10 Q Could it have been longer?

11 A No. I don't think it was longer than

12 that.

13 Q What places did you visit?

14 A What was then called Leopoldville,

15 Stanleyville, Kivu.

16 Q Kivu?

17 A Yes.

18 Q K-I-V-U?

19 A Yes. Burundi.

20 MS. RUBY: Ms. Nieusma, are you back?

21 MS. NIEUSMA: I am.

22 THE WITNESS: Could have been a couple of

23 other places, but I don't remember.

24 BY MR. SIRI:

25 Q I've heard you talk, I've heard some of


Page 352


2 your, in some of your speeches you remembered this

3 trip fondly, right?

4 A Well, "fondly" may not be the right word,

5 but I do remember it as an important event.

6 Q In what order did you visit the places you

7 just told me? Which one do you think visited first?

8 A Leopoldville.

9 Q Okay. And then after that?

10 A Stanleyville.

11 Q Then?

12 A Then the eastern part of the Congo.

13 Q Is that Kivu?

14 A Yeah. And Bukavu. Bukavu.

15 MS. RUBY: Can you spell it?

16 BY MR. SIRI:

17 Q Is that before or after Burundi?

18 A Before.

19 MS. RUBY: Can you spell those?

20 BY MR. SIRI:

21 Q Can you spell Bukavu.

22 A B-U-K-A-V-U.

23 Q So Leopoldville, then Stanleyville, then

24 Kivu, Bukum [sic], and then Burundi. So how long

25 were you in Leopoldville?


Page 353


2 A Oh, gosh, I don't, I can't answer that

3 question. I don't remember.

4 Q Approximately.

5 A A couple of weeks probably.

6 Q How long in Stanleyville?

7 A I don't know. Three, four weeks. I can't

8 possibly remember that far back.

9 Q And then how long in Kivu approximately?

10 A Oh, a short time.

11 Q And then Bakum [sic]?

12 A I'm sorry?

13 Q Bukum [sic]?

14 A Oh, Bukavu?

15 Q Bukavu.

16 COURT REPORTER: I don't know. The

17 pronunciations are not matching the spellings,

18 so I don't know what you're saying.

19 MR. SIRI: Sorry.

20 BY MR. SIRI:

21 Q B-U-K-U-V --

22 A B-U-K-A-V-U.

23 Q K-A-V-U. Sorry.

24 Bukavu, approximately how long?

25 A Couple of days.


Page 354


2 Q Okay. And then finally Burundi?

3 A Again, I don't know. Maybe a week. I'm

4 not sure.

5 Q Okay. What were you doing in

6 Leopoldville?

7 A I was examining the data on oral polio

8 vaccination in the city.

9 Q Anything else?

10 A No.

11 Q Did you vaccinate anybody?

12 A Personally, no.

13 Q How about in, what were you doing in

14 Stanleyville?

15 A I was visiting the chimpanzee laboratory

16 and talking to scientists in Stanleyville.

17 Q Talking about what?

18 A Well, about polio mainly.

19 Q And what about polio?

20 A What about polio? Obviously, they were

21 having polio, and we were talking about how to

22 protect the people against polio.

23 Q And did you the vaccinate anybody while

24 you were in Stanleyville personally?



Page 355


2 Q What did you do in Kivu?

3 A As I recall, I just visited the place.

4 Q Any purpose?

5 A I don't think so, no.

6 Q Did you vaccinate anybody personally?

7 A It was a scenic area.

8 Q Did you vaccinate anybody personally

9 there?

10 A No.

11 Q What about Bukavu?

12 A I did not do any vaccination there either.

13 Q What were you doing there?

14 A I was just visiting.

15 Q Like a tourist?

16 A Yes.

17 Q Same thing with Kivu, as a tourist?

18 A Yes.

19 Q What about Burundi?

20 A There, I had some discussions with

21 scientists.

22 Q About what?

23 A About polio.

24 Q Okay. Did you, other than that, did you

25 do anything else in Burundi?


Page 356


2 A No.

3 Q Did you vaccinate anybody personally?

4 A No.

5 Q Okay. During your entire trip, did you

6 vaccinate anybody personally?

7 A No.

8 Q So your whole trip to Belgian Congo and

9 Ruanda-Urundi, you never vaccinated anybody

10 personally?

11 A That is correct. I also stopped in

12 Kikwit, which was to observe a vaccination campaign.

13 Q That was between what cities?

14 A Well, geographically it's between

15 Leopoldville and Stanleyville. I don't recall in

16 what order I visited it.

17 Q You don't know if it was before or after

18 Stanleyville?

19 A No, I don't.

20 Q How long were you in Kikwit?

21 A Well, just a day or two.

22 Q That was just to observe a --

23 A Vaccination campaign.

24 Q -- campaign.

25 Did you observe a vaccination


Page 357


2 campaign in any of the other cities?

3 A Stanleyville probably. Leopoldville was,

4 as I said before, to collect data from prior

5 vaccination.

6 Q What were you doing in Ruanda-Urundi?

7 A Talking to people.

8 Q Again, about polio vaccine?

9 A Yes.

10 Q But not vaccinating anybody?

11 A No.

12 Q Not part of any vaccination campaign there

13 either?

14 A No.

15 Q Do you believe that someone can have a

16 valid religious objection to refusing a vaccine?

17 A No.

18 Q Do you take issue with religious beliefs?

19 A Yes.

20 Q You have said that, quote: Vaccination is

21 always under attack by religious zealots who believe

22 that the will of God includes death and disease?

23 A Yes.

24 Q You stand by that statement?

25 A I absolutely do.


Page 358


2 Q Are you an atheist?

3 A Yes.

4 Q Do you accept that some people hold

5 religious beliefs that are inherently unprovable?

6 A Yes, I'm sure they do.

7 Q You said that, quote: Vaccination is

8 always under attack by a legal system that profits

9 from the failure of most people to understand

10 risk/benefit ratios or public health issues,

11 correct?

12 A Yes.

13 Q Can you explain what you mean by that,

14 shortly?

15 A I mean that the risk from vaccines, for

16 example, is considerably less than the risk from

17 disease, but people don't necessarily understand

18 that. It's similar to the situation where people

19 may not fly, but they're willing to drive in cars

20 where the risks are much higher.

21 And what was the second point about?

22 Q Public health issues.

23 A Public health issues, yes. Not

24 understanding the importance of high vaccination

25 coverage in prevention of disease.


Page 359


2 Q One child can make a difference?

3 A One child probably doesn't make a

4 difference, but a collection of one childs do make a

5 difference.

6 Q At the most recent ACIP meeting, you spoke

7 and gave ACIP three pieces of advice, correct?

8 A Yes.

9 Q One of them was to conduct more vaccine

10 safety studies to prove the anti-vaccinationists

11 wrong, right?

12 A Yes. Correct.

13 Q Okay. If the science to prove vaccines

14 safe already exist, why would more safety studies be

15 needed to prove the anti-vaccinationists wrong?

16 A Because there are so many people, as you

17 can see on the web, who have these beliefs about

18 vaccines. And as we have discussed throughout this

19 long day, it would be valuable to have more safety

20 data.

21 Q Like a vaccinated versus unvaccinated

22 study, correct?

23 A If such a study is feasible.

24 Q Shouldn't vaccine safety studies be done

25 for the sake of making vaccines safer, not for the


Page 360


2 purpose and with the pre-determined objective of

3 proving so-called anti-vaccinationists wrong?

4 A Well, absolutely. I do not deny that

5 there are known reactions to vaccines. Fortunately,

6 they rarely are serious. I support more research on

7 every aspect of vaccines.

8 Q And your claim that they're rarely serious

9 is from your book, right?

10 A Yes.

11 Q Okay. When is the last time that you

12 received a vaccine, Dr. Plotkin?

13 A Zoster -- oh, no. Influenza vaccine

14 actually, not more than several weeks ago.

15 Q Do you get the flu shot every year?

16 A Yes.

17 Q Have you ever missed a year?

18 A No.

19 Q Have you received the zoster vaccine? It

20 sounds like you have.

21 A Yes.

22 Q Zoster, Z-O-S-T-E-R.

23 When did you receive that?

24 A I've received now two doses, and I'm

25 looking forward to receiving the new Zoster vaccine


Page 361


2 as soon as I can buy it.

3 Q Have you received a PCV13 vaccine?

4 A Yes.

5 Q Have you received a PPSV23 vaccine?

6 A Yes.

7 Q Hep B vaccine?

8 A Yes.

9 Q Let me do that again.

10 Have you received a hep B vaccine?

11 A Yes.

12 Q Have you received a hepatitis A vaccine?

13 A Yes.

14 Q Have you received a MenACWY or MPSV4

15 vaccine?

16 A I believe so. That was a long time in the

17 past because those vaccines have been available for

18 a long time. I have to check my records. But I

19 think particularly when I traveled to the Africa, I

20 believe I took it.

21 Q Have you received a MenB vaccine?

22 A Not yet, no.

23 Q Have you received a Hib vaccine?

24 A Oh, Hib. I was long past the age of Hib

25 when it was developed.


Page 362


2 Q When is the last time you got a

3 tetanus/diphtheria-containing vaccine?

4 A Within the last ten years. I don't

5 remember exactly when, but --

6 Q Do you think all adults should be required

7 to receive all vaccines on the CDC's adult

8 immunization schedule?

9 A That's somewhat of a difficult question

10 because adults, of course, have the ability to make

11 their own decisions. Tetanus is, is a vaccine that,

12 how shall I put it? I guess it's a choice whether

13 you're willing to be susceptible to tetanus or not.

14 For pertussis, I think there's

15 increasing reason that, to say that all adults

16 should be vaccinated against pertussis. So it's,

17 let's say, let's say, open to discussion at this

18 point for DTaP anyway.

19 Q You'd support a law that would require

20 adults to get the DTaP?

21 A At this point, 2017 [sic], I wouldn't

22 insist on that for all adults. I would insist on it

23 for children and adolescents. But the data, the

24 reason I say that is because the data showing

25 protection against pertussis in older adults is


Page 363


2 really not that solid, not that available.

3 Q Did you ever experience an adverse vaccine

4 reaction?

5 A Personally.

6 Q Yes.

7 A No.

8 Q Have you ever witnessed someone experience

9 an adverse vaccine reaction?

10 A I've witnessed people fainting after

11 vaccination.

12 Q Anything else?

13 A Certainly I've seen people complain of

14 pain at the injection site. And in the rubella

15 days, women complaining of joint pains after

16 vaccination. I think that's it.

17 Q When you say "fainting," after what

18 vaccine was that?

19 A Oh, actually that was, that was tetanus,

20 as I recall. It was a high school athlete.

21 Q Do you know anyone that's experienced a

22 serious adverse reaction --


24 Q Did your grandchildren receive the

25 hepatitis B vaccine on the first day of life as


Page 364


2 recommended by the CDC?

3 A Of course.

4 (Reporter clarification.)

5 Q Have your grandchildren received the

6 hepatitis B vaccine on the first day of life as

7 recommended by the CDC?

8 A Yes.

9 Q Do you think there's a safe threshold of

10 how many vaccines can be administered at one time?

11 A My answer to that is I don't know. I

12 don't think there's any evidence that the six that

13 are currently generally given together is a problem.

14 So I don't know if eventually there's some

15 theoretical threshold, but I am not aware of any

16 evidence for that yet.

17 Q Okay. But before you would say, for

18 example, getting 30 vaccines in one day was safe,

19 you'd probably want to get the data to support it?

20 A Yes.

21 Q That data doesn't yet exist obviously,

22 right?

23 A No.

24 Q Do you intend to appear at trial in this

25 matter to testify?


Page 365


2 A No, I do not.

3 Q Do you intend to appear via video

4 conference to testify in this trial in this case?

5 A Well, I haven't been asked. I suppose I

6 might consider a video conference. But no one has

7 asked me. And I'm not, I would say, very inclined

8 to do that.

9 And you know, while we're on tape, so

10 to speak, I want to stipulate, since you were so

11 interested in my income, that I am doing this

12 pro bono.

13 Q But as you sit here today, you're still

14 receiving remuneration from all four major vaccine

15 makers, correct?

16 A Yes.

17 Q And from -- so getting close to the end.

18 I don't have much left. A few more.

19 There was a controversy revolving

20 around the origin of AIDS and the OPV vaccine,

21 correct?

22 A Yes.

23 Q You disputed any connection between OPV

24 vaccine and AIDS in two papers submitted to the

25 Royal Society in which you stated, quote: There was


Page 366


2 no gun, the chimpanzees; no bullet, the virus; no

3 shooter, the manufacturer of the vaccine chimpanzee

4 cells; and no motive to use chimp cells or to hide

5 the fact, correct?

6 A Yeah. I also said the only smoke was

7 created by Mr. Hooper.

8 Q Right. Who is that?

9 A He's a British journalist, which puts him

10 at the lower end of journalism.

11 MR. SIRI: Mark this.



14 BY MR. SIRI:


16 been marked as Plaintiff's Exhibit 44. And I'm also

17 going to hand you what's been marked as Plaintiff's

18 Exhibit 45.



21 BY MR. SIRI:

22 Q Are these the two papers that you

23 submitted to the Royal Society --

24 A Yes.

25 Q -- disputing -- one second, please.


Page 367


2 -- disputing any connection between

3 OPV vaccine and AIDS --

4 A Yes.

5 Q -- correct?

6 Is everything that you wrote in these

7 two articles -- strike that.

8 Is everything written in the two

9 articles, Royal Society articles that you submitted,

10 which are marked as Exhibits 44 and 45, true?

11 A Well, I certainly hope so.

12 Q Is that -- I'm sorry, Dr. Plotkin. Is

13 that yes?

14 A Yes. Yes. And I should also add that my

15 conclusions have been verified by other scientists

16 who now have shown that HIV originated in the 1920s

17 in Cameroon.

18 Q At the end of -- Dr. Plotkin, at the end

19 of Exhibit 44, the article entitled "Untruths and

20 Consequences," you state that -- strike that.

21 I apologize. I'm sorry, Dr. Plotkin.

22 Can you look at Exhibit 45. I'm sorry.

23 The end of Exhibit 45, it states that

24 letters cited in this paper will be deposited in the

25 library of the College of Physicians of Philadelphia


Page 368


2 or the University of Leuven, L-E-U-V-E-N, correct?

3 A Yes.

4 Q Have you deposited those letters and

5 papers?

6 A I have, yes.

7 Q Okay. When did you deposit all of those

8 letters and papers?

9 A Oh, gosh, probably at least five years ago

10 now.

11 Q So all of the letters cited in this

12 document are, have been deposited in where?

13 A The College of Physicians of Philadelphia.

14 Q And they're in possession of all of the

15 letters cited in this document?

16 A Well, I believe so. I have to go over the

17 list. But that certainly was my intention, and I

18 believe I have done so.

19 Q Is that publicly available at the

20 University of Philadelphia?

21 A It's a good question. I imagine so. I

22 deposited them there basically so that they could be

23 examined after I'm dead, but --

24 Q Yeah.

25 A -- I don't know. I've never been asked.


Page 369


2 Q If they're not publicly available, would

3 you provide copies?

4 A Well, I have to ask the College of

5 Physicians to do that.

6 Q Would you authorize them to release

7 copies?

8 A I'd authorize them, sure.

9 Q Okay. If you could please take a look at

10 the --

11 A I'm not sure why you're asking the

12 question. Are you --

13 Q I'm asking the question --

14 A -- accusing me of launching AIDS? Or what

15 is the point?

16 Q Absolutely not, Dr. Plotkin. You made a

17 promise in here to deposit papers, and I'm purely

18 asking you if you made that, fulfilled that promise.

19 That's it.

20 A Yes, I did.

21 Q That's all. I'm not accusing you of

22 anything.

23 And in the other paper entitled

24 "Untruths and Consequences," in the second

25 paragraph, it says: The evidence I present is based


Page 370


2 on papers and documents of the time from my personal

3 files.

4 A Mm-hmm.

5 Q Have those also been deposited in the

6 library of Philadelphia?

7 A No. Certainly not all of them. I have

8 extensive files. I don't throw anything out.

9 Q You still have all of those?

10 A Yes.

11 Q I assume you don't have an issue sharing

12 copies of those?

13 A No. My wife would love to get rid of all

14 of them. But I don't...

15 Q So you've said that the AIDS/OPV

16 hypothesis has been disproven, correct?

17 A Yes.

18 Q A few quick questions. Just approximately

19 how many human samples that predate 1959 have been

20 tested for HIV?

21 A That predate 1959? I don't know that

22 there are any such samples available. The first

23 samples that I recall being available were from

24 1960, and they had already some HIV seropositive

25 individuals. But that was in Leopoldville. They


Page 371


2 were individuals who had not received the oral polio

3 vaccine.

4 Q So -- but in terms of samples that predate

5 1959, have there been any such samples tested for

6 HIV?

7 A I have to think about that. I -- oh,

8 well, there have been samples from elsewhere in the

9 world; but from the Belgian Congo --

10 Q Yeah.

11 A -- I don't think that any such samples

12 have been available.

13 Q Are you aware of whether there currently

14 exists any samples of polio vaccine that was in the

15 Belgian Congo at any time between 1959 and 1960?

16 A Whether the Wistar has kept them or not, I

17 don't know. Fortunately, at the time of the Royal

18 Society, I was able to go to Wistar and find

19 specimens that had been used in the Congo or from

20 the same lot that had been used in the Congo. But

21 whether that still exists or not, I have no idea.

22 Q Well, I'm curious as just, is there any

23 samples that were actually in the Belgian Congo that

24 have been, that you're aware of?

25 A That were tested?


Page 372


2 Q That were tested.

3 A I don't, really don't know the answer to

4 that question. The vaccine that was used, the oral

5 polio vaccine that was used, I believe was entirely

6 used up in the vaccination campaign. So I don't

7 think it's likely that material used in the

8 vaccination campaign was repatriated. But

9 fortunately, we had material from the same lots that

10 were used in the Congo. And that had been retained

11 at the Wistar.

12 Q But as far as you're aware, in terms of

13 actual samples, a sample that was actually in the

14 Belgian Congo, you're not -- are you saying you're

15 not aware of any such sample?

16 A No, I am not aware of any such sample.

17 Q Do you know if any such sample ever -- are

18 you aware of any such sample that existed after

19 1960?

20 A I don't -- I'm not aware that anything

21 existed.

22 Q So are you familiar with an article

23 entitled "Vaccination with the CHAT Strain of Type 1

24 Attenuated Poliomyelitis Virus in Leopoldville,

25 Belgian Congo"?


Page 373


2 A Yes.

3 Q Okay. In the article -- you're one of the

4 authors of the article?

5 A Yes.

6 Q So on page 2 of this article, it states:

7 The titer of the vaccine after a day's use was

8 checked periodically by sending frozen aliquots --

9 A Aliquots, yes.

10 Q -- thank you, aliquots, A-L-I-Q-U-O-T-S,

11 to the Wistar Institute, Philadelphia, Pennsylvania,

12 USA?

13 A Yes.

14 Q What does that mean?

15 A Well, it means that in order to be sure

16 that the vaccine used still contained enough virus,

17 they sent back samples to be titered for the

18 quantity of virus.

19 Q So they sent back samples of the oral

20 polio --

21 A Yes.

22 Q -- being used --

23 A Yes.

24 Q -- in the Belgian Congo?

25 A Yes.


Page 374


2 Q And they did that periodically?

3 A Yes.

4 Q But to your knowledge, none of those

5 survived after 1960?

6 A No. I think they were tested and then

7 discarded. I mean, they, aside from legal value,

8 they would have had no value because they were used;

9 they could not ever be used again. So they would

10 have been discarded.

11 Q It would be helpful for you if some of

12 those were saved, right?

13 A It would have been, yes. But at the time

14 nobody thought about that.

15 Q If any, if such a sample were to have

16 survived someplace on the planet, where would you

17 think that would be?

18 A Difficult to say. I mean, the laboratory

19 in Stanleyville no longer exists. I have no idea

20 where it could be. No.

21 Q Do you think such a sample will ever be

22 located?

23 A I doubt it.

24 Q Last question on this topic and we'll move

25 on. Did you or any of your Wistar colleagues ever


Page 375


2 carry any human cells, such as WISH or WI-1, or

3 polio vaccines grown in such human cells to the

4 Belgian Congo?

5 A No. At least I certainly have not.

6 Q Are you aware of any such --

7 A No, I am not aware.

8 Q -- vaccines being --

9 A No, I'm not aware of those cells being

10 carried to the Congo. If they had been, it would

11 have been for experimental purposes, certainly not

12 for vaccination purposes.

13 Q So you're not aware of them being carried

14 or used there, right?

15 A Not that I'm aware of, no.

16 Q Isn't it true that in 2014, the FDA

17 announced, quote: Although individuals immunized

18 with an acellular pertussis vaccine may be protected

19 from disease, they may still become infected with

20 the bacteria without always getting sick and are

21 able to spread infection to others, end quote?

22 A Yes. That's on the basis of the studies

23 in baboons.

24 Q That's the Warfel study?

25 A Yes.


Page 376


2 Q We discussed earlier that the baboons are

3 the -- would probably be the best surrogates for

4 humans, right?

5 A Yes.

6 Q Because you couldn't ethically expose

7 humans to pertussis, correct?

8 A Yes.

9 Q So the Warfel studies would be the best

10 evidence -- would the Warfel studies, the one in

11 2014 and 2016, which were conducted by the FDA,

12 correct?

13 A Yes.

14 Q Those would be the best evidence as to the

15 ability, as to whether or not acellular pertussis

16 vaccine prevented infection and transmission of

17 pertussis, correct?

18 A Yes.

19 Q And I think we talked about this earlier.

20 In your estimation, what percent of

21 adults would you say are actually immune to

22 pertussis?

23 A It's a very good question, and I don't

24 know the answer to that because immunity to

25 pertussis is complex. And so just measuring serum


Page 377


2 wouldn't necessarily give you a firm idea as to what

3 percentage of adults are immune.

4 But judging from the frequency of

5 pertussis in adults, I don't think the immunity

6 level is very high, because clearly adults are

7 getting pertussis.

8 Q Could you estimate what percentage of the

9 adult population in the United States you think is

10 immune to pertussis?

11 A Immune? Well, I think probably 50,

12 60 percent could be immune. But it's difficult

13 because immunity wanes.

14 Q Right.

15 A So they may, people become susceptible

16 again. And as I said now twice, there is a lot of

17 pertussis in adults. That's been shown. So a

18 significant proportion of adults are susceptible and

19 not immune.

20 Q Fifty to 60 percent is your highest

21 estimation --

22 A Yes.

23 Q -- it sounded like, right?

24 A Yes.

25 Q No more than that?


Page 378



3 Q Okay. The diphtheria vaccine creates

4 antibodies only to a toxin released by the

5 diphtheria bacteria, correct?

6 A Correct.

7 Q It doesn't create any antibodies to the

8 actual diphtheria bacteria itself?

9 A Yes, that's true. But it is also true,

10 certainly appears to be true, that if the organism

11 can't produce a toxin, it has a great difficulty in

12 surviving. And so the observation is that where the

13 vaccine is used, the organism disappears. So it's

14 very difficult to find it in the U.S., for example.

15 But in Russia where vaccination has not been always

16 complete, there are still cases of diphtheria.

17 Q Can you, how do you define

18 anti-vaccinationists or anti-vaxxers, as you've used

19 them here today?

20 A How do I define them?

21 Q Yeah. What does that mean to you? You

22 use those terms, and I'm just, I'm actually not

23 exactly sure what you mean by that.

24 A People opposed to vaccination for a

25 variety of reasons, some of which are based on false


Page 379


2 inferences from scientific data.

3 Q If somebody were opposed to vaccines

4 because they believed there was insufficient data

5 for them to make a decision about the actual risks,

6 not the benefits, but the risks, would you consider

7 that person an anti-vaxxer?

8 A If they refused to be vaccinated

9 themselves or refused to have their children

10 vaccinated, I would call them an anti-vaccination

11 person, yes.

12 Q Is there anybody who could refuse a

13 vaccine who you would not label anti-vaxxer?

14 A Yes. If there are individuals who are

15 immunosuppressed, for example, and, therefore, have

16 a contraindication to certain vaccines, that to me

17 would be a reasonable decision on their part.

18 Q But, otherwise, you believe that anybody

19 else who refuses a vaccine is doing so based on

20 misinformation?

21 A Generally speaking, yes. Now, as I said

22 before, I can imagine an adult deciding that they

23 don't want the advantages of vaccination out of, for

24 whatever reason.

25 I think the situation for children is


Page 380


2 quite different because one is making a decision for

3 somebody else and also making a decision that has

4 important implications for public health.

5 Q So in the case of an adult, you think it's

6 okay for the adult to make a decision for themselves

7 to take on a risk, even though it could implicate

8 public health, but not the case for a child?

9 A No. It depends. For example, if you're a

10 healthcare worker and you refuse to be vaccinated

11 against diseases that you could potentially transmit

12 to patients, I don't think you should have the

13 option of making that decision.

14 Q Earlier we discussed that there hasn't

15 been a wild case of polio in the United States since

16 1979, correct?

17 A Right.

18 Q The United States currently only uses

19 inactivated polio vaccine, correct?

20 A Yes.

21 Q The United States does not use oral polio

22 vaccine, correct?

23 A Correct.

24 Q If there were an outbreak of polio in the

25 United States --


Page 381


2 A Yes.

3 Q -- isn't it true that we would have to,

4 that we would have to return to using oral polio

5 vaccine to stop the spread of polio in the United

6 States?

7 A It might well be the case; however,

8 individuals who have received the inactivated

9 vaccines will not themselves get polio. They may

10 get infected and transmit to others, which is one of

11 the reasons why one might resort to OPV. But the

12 individual himself would not be susceptible.

13 Q Is that because the IPV creates IGG

14 antibodies in the blood towards --

15 A Yes.

16 Q But it doesn't create IGA immunity in the

17 intestinal tract?

18 A Correct.

19 Q And it is in the intestinal tract where

20 the polio virus multiplies, correct?

21 A Yes.

22 Q So a person vaccinated with IPV can still

23 become infected and transmit polio virus, correct?

24 A Yes, although in point of fact, IPV does

25 protect the nasopharynx. So in this country where


Page 382


2 hygiene and sewage, et cetera, are good, the

3 possibility of transmitting from an IPV vaccinee is

4 much less than it is, let's say, in Africa where

5 sewage contamination is great.

6 Q When you say nasopharynx, what is that?

7 A The throat.

8 Q So you're saying IPV does create immunity

9 within the throat?

10 A Yes.

11 Q There are studies that show that?

12 A Yes, absolutely.

13 Q Okay. How do those studies make that

14 determination?

15 A Well, by culturing people who are exposed

16 to polio, who have had IPV, and also by showing that

17 antibody diffuses into the throat much better than

18 it does into the gut.

19 Q In the Warfel study -- I'm sorry. Strike

20 that.

21 Do you know the names of those

22 studies, by any chance?

23 A Gosh, again, they're in the book.

24 Q Are they in your book?

25 A Yes, absolutely.


Page 383


2 Q Okay. And in terms of efficacy, does IPV

3 vaccination as -- in childhood last a lifetime?

4 A You know, that's an interesting question,

5 and I think the answer is yes. Studies that have

6 been done have shown quite good persistence of

7 antibody after IPV. Now, does it last forever? I

8 can't say that, but certainly lasts a long time.

9 Q How about 30 years after vaccination; what

10 do you think the efficacy is approximately?

11 A I would just be totally speculating, but I

12 think most people would still be protected because

13 you don't need much antibody against polio to be

14 protected. Levels of dilutions of one to four, one

15 to eight are probably protective.

16 Q But you're not sure?

17 A I'm not sure about 30 years. I'm sure

18 about the levels that are protective.

19 Q Thirty years, you're not sure about what

20 percent of the people vaccinated are still immune to

21 polio?

22 A No. But I do know that that persistence

23 is good and that the likelihood is that most people,

24 even 30 years, will still be protected.

25 Q Forty years?


Page 384


2 A I can't really guess any more than that.

3 Q The data doesn't exist?

4 A No. I don't believe they exist.

5 Q Well, what do you estimate is the current

6 efficacy of the mumps vaccine shortly after

7 vaccination?

8 A Oh, shortly after vaccination, there's no

9 doubt that the efficacy is high. It's 80,

10 90 percent. And after two doses, immediately after

11 two doses, the efficacy is very high.

12 Unfortunately, the efficacy

13 diminishes with time, and that has caused a problem

14 in universities that have outbreaks of mumps because

15 the college kids are --

16 Q No longer immune?

17 A -- intimately associated. Yes.

18 Although the efficacy even then is

19 probably in the order of 70, 80 percent.

20 Q 70, 80 percent. What about, what about 30

21 years after vaccination; what's the efficacy?

22 A I have no idea.

23 Q Twenty years?

24 A I don't think studies have been done more

25 than ten years after vaccine.


Page 385


2 Q What do you estimate is the current

3 efficacy of the rubella vaccine ten years after

4 vaccination?

5 A Based on the data that are available, it

6 is very high. The so-called B cell memory after

7 rubella vaccine, I'm happy to say, is very good.

8 Q How about 20 years?

9 A I think it will still be present.

10 Q Thirty years?

11 A I think so.

12 Q High efficacy still, you think?

13 A I think so.

14 Q But no study has been done?

15 A Actually, there are studies, at least

16 20-year studies. I'm not sure about 30, but

17 immunity is very long-lasting.

18 Q And -- okay. And the studies would be in

19 your book?

20 A Yes.

21 Q What would you estimate is the current

22 efficacy of the measles vaccine 20 years after

23 vaccination?

24 A Well, again, it appears to be quite good.

25 Twenty years, again, I'm, don't have it in my head


Page 386


2 as a study done 20 years later.

3 But certainly studies done sometime

4 after vaccination have shown good persistence of

5 antibodies. And once again, you don't need a whole

6 lot of antibody to prevent you from getting measles.

7 Q Do you know a percentage?

8 A Of?

9 Q Of people that are still immune 20 years

10 out from the measles vaccine?

11 A Not off the top of my head, but I feel

12 relatively sure that it's quite high.

13 Q Is it important to get a tetanus vaccine?

14 A Well, it's important if you don't want to

15 get tetanus, yes.

16 Q The tetanus vaccine was introduced into

17 routine child schedule in the late 1940s, correct?

18 A Yes.

19 Q When the tetanus vaccine was introduced

20 there were only about four cases of tetanus per

21 million people, correct?

22 A If you say so. I don't remember.

23 Q Are you familiar with what, the CDC Pink

24 Book?

25 A Yes.


Page 387


2 Q If the CDC Pink Book said that it was four

3 cases of tetanus per million, would you dispute

4 that?

5 A I'll accept that.

6 Q You do accept that. And that's just the

7 number of cases, not deaths, right?

8 A Yes.

9 Q And you think it's a public health

10 imperative for people to be vaccinated against

11 tetanus, correct?

12 A I think it's the wise thing to do if you

13 don't want to be under risk of getting tetanus if

14 you have an injury.

15 Q To prevent something that was a few cases

16 in a million, correct?

17 A Yes. But a deadly disease.

18 Q Do we know whether the tetanus vaccine

19 causes more or less than a few cases of serious

20 adverse reactions after vaccination?

21 A I don't believe it causes a whole lot of

22 serious reactions, no.

23 Q I'm going to show you what's --

24 MS. NIEUSMA: Do you know how much longer

25 we have to go? Just so I have an idea.


Page 388


2 MR. SIRI: Yeah, sure. I think that we've

3 only got about 15 more minutes.

4 VIDEO OPERATOR: That's exactly how much

5 we have left on the tape.

6 MS. NIEUSMA: Very good.

7 MR. SIRI: We're almost done.



10 BY MR. SIRI:

11 Q The CDC and FDA maintained something

12 called the Vaccine Adverse Events Reporting System,

13 correct?

14 A Yes.

15 Q And that's where anybody, including

16 doctors, can go and report what they believe to be

17 an adverse reaction from a vaccine --

18 A Right.

19 Q -- right?

20 A Correct.

21 Q There's no, anybody can submit a report,

22 right?

23 A That's correct.

24 Q Okay. And the FDA and CDC compiled that

25 data and make it available online, correct?


Page 389


2 A Yes.

3 Q Okay. I'm going hand you a, what's been

4 marked as Plaintiff's Exhibit 46. Okay? And this

5 is a printout of the VAERS data for all adverse

6 reactions reported to tetanus-containing vaccines in

7 the last ten years.

8 If you take a look, do you see that

9 in the last ten years, there have been 985 deaths

10 reported --

11 A Yes.

12 Q -- to have followed any tetanus-containing

13 vaccine?

14 A Yes.

15 Q That would average to about 98.5 reports

16 of death per year --

17 A Yes.

18 Q -- over the last ten years.

19 Okay. And there's also 23,981

20 emergency room or office visits after

21 tetanus-containing vaccine in the last ten years?

22 A Yes.

23 Q And it also lists, last one, 1,256

24 permanent disabilities reported after

25 tetanus-containing vaccine in the last ten years,


Page 390


2 correct?

3 A Yeah.

4 Q That would be about an average of 125 per

5 year, right?

6 A Yes.

7 Q So, but we don't, because these are just

8 reports and not done in some kind of randomized,

9 controlled study, we don't actually know whether or

10 not the tetanus vaccine is causing these deaths and

11 permanent disabilities, correct?

12 A Correct.

13 Q Okay. But it's possible it could be,

14 correct?

15 A It's, anything is possible, yes.

16 Q Don't you think a study should be done to

17 determine -- strike that. Strike that.

18 Isn't it true that VAERS only

19 receives a tiny fraction of the reportable adverse

20 events after vaccination?

21 A Well, I can't give you a percentage, but

22 all physicians are asked to report putative

23 reactions to the VAERS system. So I don't think the

24 VAERS system covers a tiny portion of alleged

25 reactions. I think, rather, probably most are


Page 391


2 reported. But I, I cannot confirm that.



5 BY MR. SIRI:

6 Q Dr. Plotkin, I'm going to show you what's

7 been marked as Plaintiff's Exhibit 47. This is a

8 report entitled "Electronic Support for Public

9 Health - Vaccine Adverse Events Reporting System,"

10 correct?

11 Let me know when you're ready,

12 Dr. Plotkin.

13 A I'm ready.

14 Q The title of this report, Dr. Plotkin, is

15 "Electronic Support for Public Health - Vaccine

16 Adverse Event Reporting System," correct?

17 A Yes.

18 Q And this was a study conducted by Harvard

19 Medical School and the Harvard Pilgrim Healthcare,

20 correct?

21 A Yes.

22 Q And it was are done via a grant from an

23 agency within HHS, correct?

24 A Yes.

25 Q And the purpose of this study was to


Page 392


2 attempt to automate VAERS reporting?

3 A Yes.

4 Q The reason that Harvard did this study and

5 the reason that HHS paid for it, if you look at

6 page 6 --

7 A Yes.

8 Q -- do you see where it says: Fewer

9 than 1 -- it's right in the middle paragraph: Fewer

10 than 1 percent of vaccine adverse events are

11 reported?

12 A Well, yes, I see the statement. I don't

13 see the reference, but...

14 Q Let's take a look at the results of that

15 study, then. If you go to the first sentence of the

16 page that you're on right now --

17 A Yeah.

18 Q -- where it says "results," isn't it true

19 that it says: Preliminary data were collected from

20 June 2006 through October 2009 on 715 -- 715,000

21 patients?

22 A Yes.

23 Q And 1.4 million doses of 45 different

24 vaccines were given to 376,452 individuals?

25 A Yes.


Page 393


2 Q So about 376,000 individuals received a

3 vaccine, correct?

4 A Yes.

5 Q Out of these doses, 35,570 possible

6 reactions were identified, correct?

7 A Yes.

8 Q So out of 376,000 people that received

9 vaccines, they identified 35,570 possible reactions,

10 right?

11 A Yes.

12 Q And now --

13 A Well, it's out of 1.4 million, which is

14 2.6 percent.

15 Q Doses, correct?

16 A Yes.

17 Q Meaning maybe some individuals had --

18 A More than one vaccine.

19 Q And had reactions at different times to

20 different vaccines, right?

21 A Yes.

22 Q Maybe some people were more susceptible to

23 a vaccine reaction, and so they got, had a reaction

24 every time they had a vaccine, right?

25 A Well, we don't know that.


Page 394


2 Q We don't know.

3 Assuming that each individual only

4 had one vaccine reaction, then 10 percent of the

5 individuals would have had a vaccine reaction?

6 A Mm-hmm. Yes.

7 Q All right. So, now, at the beginning of

8 this study, the CDC was cooperating with these grant

9 participants, correct -- grant recipients, correct?

10 A Yes.

11 Q And they helped define what is an adverse

12 reaction, right?

13 A Yes.

14 Q And they helped define the algorithms to

15 use, right?

16 A Yes.

17 Q And they also helped to define what

18 reports should be excluded, correct?

19 A I guess so.

20 Q What events, I'm sorry, should be excluded

21 from being considered, you know, reportable, right?

22 A Yes.

23 Q After, however, they collected this data

24 and they generated these 35,000 reports, they then

25 wanted to submit those reports to VAERS and automate


Page 395


2 it so that those reports could continue to be

3 submitted, correct?

4 A Yes.

5 Q But the CDC wouldn't cooperate with them,

6 correct?

7 A Well, I have no idea whether that's true

8 or not.

9 Q On page 5, Dr. Plotkin, at the end of the

10 second paragraph, it says: Real -- does it say:

11 Real data transmission of nonphysician-approved

12 reports to the CDC were unable to commence by the

13 end of this -- as by the end of this project, the

14 CDC had yet to respond to multiple requests to

15 partner for this activity?

16 Is that what it says?

17 A That's what it says.

18 Q Okay. So, and this study says that less

19 than 1 percent of adverse events are reported to

20 VAERS, right?

21 A Well, I have to check that, but I think

22 that's correct.

23 Q Okay. Are you aware that there are other,

24 other governmental reports that make similar

25 estimates for VAERS?


Page 396


2 A I'm aware that not everything is reported

3 to VAERS, yes.

4 Q Are you aware that governmental reports

5 show that, that governmental reports like this one

6 show that the rate of reporting to VAERS is

7 extremely low, and in this instance they say Harvard

8 said less than 1 percent?

9 A Yes, apparently, yes. However, it has to

10 be reminded that reporting to VAERS is supposed to

11 occur whether or not you think there's been a

12 reaction. So whether or not the reactions are true

13 or not is not something that VAERS decides.

14 Q Right. But let's just assume for a second

15 here, so if, let's go back to what's been marked as

16 Exhibit 46, okay? Let's assume that a full

17 1 percent of associated adverse events are reported;

18 wouldn't that take the number of deaths to 98,000,

19 then, that were associated with the vaccine?

20 A I think it's likely the deaths are

21 reported more often than trivial reactions. So I

22 wouldn't be able to extrapolate from that number.

23 Q Right.

24 A But, you know, obviously death is more

25 dramatic.


Page 397


2 Q Let me show you, I think, one final

3 exhibit.

4 VIDEO OPERATOR: We have six minutes left

5 on the disc.

6 BY MR. SIRI:





11 BY MR. SIRI:

12 Q This is the VAERS report for all adverse

13 events for all vaccines just since January of 2016.

14 Do you see that?

15 A Yes.

16 Q If this --

17 A My wife is getting upset.

18 Q Well, don't tell her you offered her up

19 for a deposition.

20 If this represents even 3 percent or

21 5 percent of reported events, doesn't this concern

22 you in that maybe it really indicates -- strike

23 that.

24 It reports 751 life-threatening

25 reactions, correct?


Page 398


2 A Yes.

3 Q And that's only since January of 2016,

4 correct?

5 A Yes.

6 Q If that's only, if that's a full

7 1 percent, then that would be 75,000

8 life-threatening reactions that would have been

9 reported, correct?

10 A That's the arithmetic, yes.

11 Q That's the kind of event that would happen

12 pretty soon after vaccination, correct?

13 A Well, events that happen after

14 vaccination, yes --

15 Q Okay.

16 A -- but not necessarily because of

17 vaccination.

18 Q But until a properly controlled saline

19 placebo study is actually done or -- strike that.

20 Until we compare the total health

21 outcomes -- strike that.

22 Would you support a study that

23 compared total health outcomes between vaccinated

24 and unvaccinated children, Dr. Plotkin?

25 A Will I support such a study? Yes. If the


Page 399


2 protocol was scientifically valid, yes, I would

3 support such a study. I don't really put much faith

4 into the VAERS system for a number of reasons, some

5 of which you've cited.

6 I take much more, I put much more

7 confidence in the vaccine safety data, data which

8 are better controlled and which come from

9 institutions that see large numbers of patients.

10 Q Would you work to support such a study?

11 A Again, if such a study were scientifically

12 feasible, I would support it, yes.

13 Q Don't you want to know what the results of

14 that study show?

15 A If the study is done, yes, of course.

16 Q In terms of the Vaccine Safety Datalink

17 which you just mentioned, that's not available to

18 the public, correct?

19 A I think they publicly report in the

20 scientific literature --

21 Q If independent researchers want to get

22 access to the VSD while --

23 A I, I don't know what the circumstances are

24 regarding access to data.

25 Q Well, then I won't --


Page 400


2 A I simply don't know.

3 Q I won't ask you questions about that, if

4 you don't know it.

5 VIDEO OPERATOR: Two minutes.

6 MR. SIRI: Okay. Well, I am, I'm done

7 with my questioning. And I will, if opposing

8 counsel intends to ask any questions, then I

9 reserve to ask some rebuttal questions as well.

10 But, otherwise, I'm done with my questioning

11 for today.

12 MS. NIEUSMA: You know what? If

13 Dr. Plotkin is going to testify, I'm going to

14 have him here in Michigan, so I'm not concerned

15 about it. Let's just call it a day.

16 Dr. Plotkin, I'll give you a call tomorrow

17 if you're available for a quick phone call.

18 THE WITNESS: Actually, no. I'll be in a

19 meeting in Philadelphia, but I will be

20 available on Monday.

21 MS. NIEUSMA: Perfect. I will call you on

22 Monday.

23 THE WITNESS: Okay.

24 COURT REPORTER: Counsel, don't hang up,

25 please.


Page 401



3 VIDEO OPERATOR: This ends disc five. It

4 concludes the deposition of Dr. Stanley

5 Plotkin. We are going off the record. The

6 time is 18:43.

7 COURT REPORTER: Ms. Nieusma, do you need

8 a copy of today's transcript?

9 MS. NIEUSMA: I do not.

10 COURT REPORTER: Is the witness going to

11 read and sign?

12 MS. NIEUSMA: He certainly can. It's

13 generally not something we do around here. But

14 he can do it if anybody wants him to.

15 (Discussion off the record.)

16 MR. SIRI: I'll talk to you after.

17 (Witness excused.)

18 (Deposition concluded at 6:42 p.m.)

19 _____________________

20 Witness Signature

21

22

23

24

25


Page 402

2 C E R T I F I C A T E

3

4 COMMONWEALTH OF PENNSYLVANIA :

5 :

6 COUNTY OF PHILADELPHIA :

7

8

9 I, MAUREEN BRODERICK, Registered

10 Professional Reporter - Notary Public, within and

11 for the Commonwealth of Pennsylvania, do hereby

12 certify that the proceedings, evidence, and

13 objections noted are contained fully and accurately

14 in the notes taken by me of the preceding

15 deposition, and that this copy is a correct

16 transcript of the same.

17

18

19

20

________________________

21

MAUREEN BRODERICK

22

Registered Professional

23

Reporter - Notary Public

24

25 Dated: January 16th, 2018


Page 403

1 ERRATA SHEET

2 Case Name:

3 Deposition Date:

4 Deponent:

5 Pg. No. Now Reads Should Read Reason

6 ___ ___ __________ __________ ____________________

7 ___ ___ __________ __________ ____________________

8 ___ ___ __________ __________ ____________________

9 ___ ___ __________ __________ ____________________

10 ___ ___ __________ __________ ____________________

11 ___ ___ __________ __________ ____________________

12 ___ ___ __________ __________ ____________________

13 ___ ___ __________ __________ ____________________

14 ___ ___ __________ __________ ____________________

15 ___ ___ __________ __________ ____________________

16 ___ ___ __________ __________ ____________________

17 ___ ___ __________ __________ ____________________

18 ___ ___ __________ __________ ____________________

19 ___ ___ __________ __________ ____________________

20

_____________________

21

Signature of Deponent

22

SUBSCRIBED AND SWORN BEFORE ME

23 THIS ____ DAY OF __________, 2018.

24 ____________________

25 (Notary Public) MY COMMISSION EXPIRES:__________

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